| Model Number U1100 |
| Device Problem
False Positive Result (1227)
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| Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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For 5 events, the investigation did not identify a product problem.The cause of the event could not be determined as no customer material was received.For 2 event, the investigation could not identify a product problem.The cause of the event could not be determined.For 1 event, investigations of retention test strip material and the customer's returned meter and test strips showed no discrepant high nitrite results.The investigation could not identify a product problem.The cause of the event could not be determined.For 1 event, the instrument was received for investigation; the test strip tray was not returned.The instrument was clean and showed no damage.The test strips with lot 39664800 were also returned.The vial was not closed correctly.The material showed no abnormalities.The retention material of lot 39664800 also showed no abnormalities.For 2 events, the customer returned the meter and the test strips.Retention material was tested along with the customer's test strips.The results from all tests were acceptable and no false positive results were received.Another test strip lot was used on the customer's meter and no false positive results were received.The investigation did not identify a product problem.The cause of the event could not be determined.For 1 event, the instrument was received for investigation; the test strip tray was not returned.The instrument was clean and showed no damage.Retention material of strip lot 39664800 showed no abnormalities.For 1 event, the customer returned the meter and the test strips.Retention material was tested along with the customer's test strips.The results from all tests were acceptable and no false positive results were received.The investigations for the remaining events are ongoing.For 2 of the events, no follow up actions were taken.For 1 of the events, the customer replaced the test strip tray and no further issues were noted.Retention material of strip lot 38055300 was measured on a urisys 1800 analyzer and a cobas u411 analyzer with native urine and a nitrite-dilution-series.The results of the measurements fulfilled the requirements.No false positive results were observed.For 7 of the events, the customer replaced the test strip tray and no further issues were noted.For 1 of the events, the customer was sent a new test strip tray and test strips.For 2 of the events, the customer was sent a new test strip tray.For 4 of the events, the customer replaced the strip tray.For 9 of the events, the customer replaced the strip tray which did not resolve the issue.For 1 of the events, the customer's products have been requested for return.For 1 of the events, the customer changes the test strip tray approximately every 4 months.For 1 of the events, the customer stated the test strip tray was not going in and out of the meter as it should.The meter and test strip tray were cleaned and the meter was calibrated.For 1 of the events, the customer re-calibrated the meter and tested the patients on a different meter.The customer returned the meter.The meter had an old test strip tray inserted.For 1 of the events, the retention material of lot 39664800 and lot 39009500 were visually tested with a nitrite dilution series and native urine and both lots showed no abnormalities.For 1 of the events, the retention material of test strip lot 390095 was visually tested with a nitrite dilution series and native urine.The retention material showed no abnormalities.For 1 of the events, the retention material of lot 39664800 was visually tested with a nitrite dilution series and native urine.For 1 of the events, the customer used the same test strips with a different instrument and they worked fine.The instrument was replaced.For 1 of the events, the analyzer was received for investigation and would not start.No further investigation was possible the reported event involved an automated analytical device which is serviced in the field and not routinely returned for investigation.This device is not labeled for single use and is not reprocessed or reused.Serial number: (b)(4).
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Event Description
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This report summarizes 63 malfunction events.Questionable false positive nitrites results were generated by urisys 1100 analyzers the events involved an unspecified number of patient samples.The patients' ages were: 26 - 77 for eight patients.The remaining patients' ages were requested, but were not provided.The patients' weights were: 150 - 216 lbs.For two patients.The remaining patients' ages were requested, but were not provided.The patients' genders were: there were seven females and two males.The remaining patients' genders were requested, but were not provided.The patients' races were requested, but were not provided.The patients' ethnicities were requested, but were not provided.
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Manufacturer Narrative
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For four of the pending events, the customer returned the meter and the test strips.Retention material was tested along with the customer's test strips.The results from all tests were acceptable and no false positive results were received.For six other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined as no customer material was received.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions include the following: the retention material of lot 38055500 was measured on an iu urisys 1800 / cobas u411 with native urine and a nitrite dilution series and was visually checked.The customer material of lot 38055502 was provided for investigation and the vial was tested for tightness.The vial of the customer material of lot 38055502 did not pass the test for tightness.After changing the test strip vial lid, the test for tightness was also not passed.The customer's urisys 1100 analyzer was also provided for investigation.The analyzer and test strip tray were cleaned.Additionally, the customer urisys 1100 analyzer was measured with another strip lot (43065200) with native urine.The retention material and the customer material showed no false positive results and fulfilled requirements.For one other of the pending events, the customer returned the meter and the test strips (lot 40396202).Retention material was tested along with the customer's test strips.The results from all tests were acceptable.The customer material of lot 40396202 was measured on an iu cobas u411 / urisys 1800 with native urine and a nitrite dilution series.The retention material of lot 40396200 was measured on an iu cobas u411 / urisys 1800 with native urine and a nitrite dilution series.The retention material and customer material were checked by visual reading with native urine and a nitrite dilution series.Additionally, the customer urisys 1100 analyzer (b)(6) was measured with another strip lot (43065200) with native urine.The retention material and the customer material showed no false positive results and fulfill the requirements.The investigation did not identify a product problem.The cause of the event could not be determined.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.The reporter's meter and test strips were provided for investigation.The meter was clean and showed no damages.The test strip material showed no abnormalities.A malfunction of the meter serial port and printer were found.The customer material of test strip lot 38055502 and the retention material of lot 38055500 were both measured on a retention cobas u411 and retention urisys 1800 analyzer and checked by visual reading with a nitrite dilution series and native urine.The results of the measurements from both materials fulfilled requirements.No false positive results were observed.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.The reporter's meter and test strips were provided for investigation.The meter was clean and showed no damages.The test strip material showed no abnormalities.The customer material of test strip lot 40396202 and the retention material of lot 40396200 were both measured on a retention cobas u411 and retention urisys 1800 analyzer and checked by visual reading with a nitrite dilution series and native urine.The results of the measurements from both materials fulfilled requirements.No false positive results were observed.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.The reporter's meter and test strips were provided for investigation.The lid for the test strips was open when the material arrived.The test strips showed no abnormalities.The customer material of lot 39664803 was measured on an iu cobas u411 / urisys 1800 with native urine and a nitrite dilution series.The retention material of lot 39664800 was measured on an iu cobas u411 / urisys 1800 with native urine and a nitrite dilution series.The retention material and the customer material were checked by visual reading with native urine and a nitrite dilution series.Additionally, the customer urisys 1100 analyzer (b)(6) was measured with another strip lot #43065200 with native urine.The retention material and the customer material showed no false positive results and fulfills our requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined as no customer material was received.The customer returned the test strips.Retention material was tested along with the customer's test strips.The results from all tests were acceptable and no false positive results were received.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions include the following: the retention material of lot 39009502 was measured on an iu urisys 1800 / cobas u411 with native urine and a nitrite dilution series and was visually checked.The customer material of lot 39009502 was provided for investigation.The customer's urisys 1100 analyzer was also provided for investigation.The analyzer and test strip tray were cleaned.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions include the following: the retention material of lot 40396202 was measured on an iu urisys 1800 / cobas u411 with native urine and a nitrite dilution series and was visually checked.The customer material of lot 40396202 was provided for investigation.The customer's urisys 1100 analyzer was also provided for investigation.The analyzer and test strip tray were cleaned.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions include the following: the retention material of lot 39664803 and lot 36897002 were measured on an iu urisys 1800 / cobas u411 with native urine and a nitrite dilution series and was visually checked.The customer material of lot 39664803 and lot 36897002 were provided for investigation.The customer's urisys 1100 analyzer was also provided for investigation with no issues found.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions include the following: the retention material of lot 38055500 and 41515900 were measured on an iu urisys 1800 / cobas u411 with native urine and a nitrite dilution series and was visually checked.The customer material of lot 38055502 and lot 41515903 were provided for investigation.The customer's urisys 1100 analyzer was also provided for investigation with no issues found.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions include the following: the customer's meter and test strips (lot were provided for investigation.The received material showed no signs of abnormalities.The customer material and retention material of lot 415159 was measured on an iu cobas u411 / urisys 1800 with native urine and a nitrite dilution series.The customer and retention material were also checked by visual reading with native urine and a nitrite dilution series.Additionally, the customer urisys 1100 analyzer was measured with another strip lot (43065200) with native urine.The retention material and the customer material showed no false positive results and fulfilled requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions include the following: the customer's analyzer and test strips of lot 38055301 were provided for investigation.When the material arrived, the test strip vial lid was not on the test strip vial.The test strips showed signs of discoloration.The retention material of lot 380553 was measured on a retention cobas u411 / urisys 1800 with native urine and a nitrite dilution series.The retention material was checked by visual reading with native urine and a nitrite dilution series.Additionally, the customer's urisys 1100 analyzer was measured with another retention strip lot (43065200) with native urine.The retention material and the customer material showed no false positive results and fulfilled requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions include the following: the customer returned analyzer serial number (b)(6)and test strip lot 41516501.No abnormalities were observed.The retention material and the customer material were checked by visual reading with native urine and a nitrite dilution series.The customer material of lot 41516501 was measured on an iu cobas u411 / urisys 1800 with native urine and a nitrite dilution series.Because of limited test strips, the measurements could only be carried out with one test strip per solution.The retention material of lot 41516500 was measured on an iu cobas u411 / urisys 1800 with native urine and a nitrite dilution series.Additionally, the customer urisys 1100 analyzers (b)(6) was measured with another strip lot 43065200 with native urine.The retention material and the customer material showed no false positive results and fulfill the requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions include the following: one vial of combur 10 test ux lot 40396202 was received from the customer.The test strips show no abnormalities.The customer analyzer urisys 1100 analyzer international, s/n (b)(6), was received from the customer.The device and tray were clean.The customer material of lot 40396202 was measured on an iu cobas u411 / urisys 1800 with native urine and a nitrite dilution series.The retention material and customer material were checked by visual reading with native urine and a nitrite dilution series.Additionally, the customer urisys 1100 analyzer (b)(6) was measured with another strip lot #43065200 with native urine.The retention material and the customer material showed no false positive results and fulfill our requirements.For one other of the pending events, the reporter's meter and test strips were provided for investigation.The meter was clean and showed no damages.The test strip material showed no abnormalities.The customer material of test strip lot 40396202 and the retention material of lot 40396200 and lot 39664800 were both measured on a retention cobas u411 and retention urisys 1800 analyzer and checked by visual reading with a nitrite dilution series and native urine.The results of the measurements from both materials fulfilled requirements.No false positive results were observed.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions for this event include: the customer's urisys 1100 analyzer was provided for investigation.The device was cleaned.The retention material of lot 38055400 was measured on a retention cobas u411 / urisys 1800 and was also checked by visual reading with native urine and a nitrite dilution series.Additionally, the customer urisys 1100 analyzer was measured with another strip lot (43065200) with native urine.The retention material and the customer material showed no false positive results and fulfilled requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.The retention materials of lot 39664800 was measured on an cobas u411 / urisys 1800 and were visually measured with native urine and a nitrite dilution series.Additionally, the customer urisys 1100 analyzer (b)(6) was measured with another strip lot #43065200 with native urine.The retention material and the customer material showed no false positive results and fulfilled the requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.The retention materials of lot 40396200 was measured on an cobas u411 / urisys 1800 and were visually measured with native urine and a nitrite dilution series.Additionally, the customer urisys 1100 analyzer (b)(6) was measured with another strip lot #43065200 with native urine.The retention material and the customer material showed no false positive results and fulfilled the requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.The customer material of lot 40396202 and the retention materials of lot 40396200 and lot 39664800 were measured on an cobas u411 / urisys 1800 and were visually measured with native urine and a nitrite dilution series.Additionally, the customer urisys 1100 analyzer (b)(6) was measured with another strip lot #43065200 with native urine.The two additional test strip trays were installed on an iu urisys 1100 analyzer and were also measured with test strip lot 43065200.The retention material and the customer material showed no false positive results and fulfilled the requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.The customer's urisys 1100 urine analyzer, without test strip tray was received for investigation.The device was clean and showed no damages.The customer analyzer was measured with another strip lot #43065200 with native urine.The measurements showed no false positive results and fulfilled the requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.The customer's urisys 1100 analyzer was received for investigation.The test strip tray was slightly dirty.The retention material of lot 39664800 was measured on an iu cobas u411 / urisys 1800 and was checked by visual reading with native urine and a nitrite dilution series.The retention material and the customer material showed no false positive results and fulfill the requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions for this event include: the customer's urisys 1100 analyzer and remaining test strips were received for investigation.The test strip material showed no abnormalities and the analyzer was clean, with no damages.The customer material of lot 40396202 and the retention materials of lot 40396200 and lot 39664800 were measured on a retention cobas u411 / urisys 1800 and were visually measured with native urine and a nitrite dilution series.Additionally, the customer urisys 1100 analyzer was measured with another strip lot (43065200) with native urine.The retention material and the customer material showed no false positive results and fulfilled requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions for this event include: the customer's test strips and urisys 1100 analyzer were provided for investigation.The test strips showed signs of discoloration and the vial was damaged.The analyzer and tray were cleaned.The retention material of lot 41516500 was measured on a retention cobas u411 / urisys 1800 and was checked by visual reading with native urine and a nitrite dilution series.Additionally, the customer urisys 1100 analyzer was measured with another strip lot (43065200) with native urine.The retention material and the customer material showed no false positive results and fulfilled requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions for this event include: the customer's test strips and urisys 1100 analyzer were provided for investigation.The analyzer was clean and showed no damages.The test strips showed no abnormalities.The retention material of lot 39009500 and the customer material of lot 39009502 were both measured on a retention u411/urisys 1800 analyzer and were checked by visual reading with a nitrite dilution series, a leucocytes dilution series, a protein dilution series, a ketone dilution series, an erythrocytes dilution series and native urine.The customer urisys 1100 analyzer did not start and could not be investigated.The measurements showed no abnormalities.The customer material and retention material fulfilled requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions for this event include: the customer's instrument was returned without a test strip tray.The device is clean and showed no damages.The retention material of lot 39009502 was measured on an iu cobas u411 / urisys 1800 and was visually tested with native urine and a nitrite dilution series.The retention material and customer material were checked by visual reading with native urine and a nitrite dilution series.Additionally, the customer's urisys 1100 analyzer was measured with another strip lot (43065200) with native urine.The retention material and the customer material showed no false positive results and fulfill the requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions for this event include: the customer's analyzer was provided for investigation.No further investigation of the device was possible as the test trip tray lid was missing, the printer lid was missing, an unknown magnetic spare part was sticking to the test strip tray, and there was contamination within the printer compartment and inside the instrument.A self check of the analyzer could not be performed due to the missing printer lid as an error occurs indicating the printer compartment should be closed.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions for this event include: the customer returned both urisys 1100 analyzers.(b)(6) had the test strip tray but no test strip downholder.The instrument was clean and showed no damage.(b)(6) had a test strip tray but the instrument would not turn on when connected to a power supply.No further investigation is possible for serial number (b)(6)as it won't turn on.For (b)(6): the retention material of lot 38055400 was measured on an iu cobas u411 / urisys 1800 with native urine and a nitrite dilution series.The retention material of lot 38055400 was checked by visual reading with native urine and a nitrite dilution series.Additionally, the customer's urisys 1100 analyzer (b)(6)was measured with another strip lot (43065200) with native urine.The retention material and the customer urisys 1100 analyzer showed no false positive results and fulfill the requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions for this event include: the customer's analyzer was provided for investigation.The device was clean and showed no damages.The customer's urisys 1100 analyzer was measured with retention strip lot number 43065200 with native urine.The retention material showed no false positive results and fulfilled requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions for this event include: the customer returned the analyzer with a test strip tray.The device was clean and showed no damage.The meter was tested with strip lot (43065200) with native urine.The testing material showed no false positive results and fulfill the requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.One vial of lot 39664803 combur 10 test ux 100t and the urisys 1100 analyzer international serial number (b)(6)were received for investigation.The material was clean and show no abnormalities.The retention material of lot 39664800 was measured on a cobas u411 / urisys 1800 with native urine, a leukocytes dilution series, a blood dilution series, and a nitrite dilution series.The customer material of lot 39664803 was measured on a cobas u411 / urisys 1800 with native urine and a nitrite dilution series with only one test strip, because only five test strips were available.The retention material of lot 39664800 was checked by visual reading with native urine, a leukocytes dilution series, a blood dilution series, and a nitrite dilution series.The customer material of lot 39664803 was checked by visual reading with native urine and a nitrite dilution series and a concentration of 10 ery/¿l each with only one test strip, because only five test strips were available.Additionally, the customer urisys 1100 analyzer (b)(6) was measured with another strip lot #43065200 with native urine.The retention material and customer material showed no false positive results and fulfill our requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.One urisys 1100 analyzer serial number (b)(6)and one vial of combur 10 test ux 100t, lot 40396202 were received for investigation.The material showed no abnormalities.The device was clean and showed no damages.The retention material of lot 40396200 and the customer material of lot 40396202 were both measured on a u411/urisys 1800 analyzer and were checked by visual reading with a nitrite dilution series and native urine.Additionally, the customer urisys 1100 analyzer (b)(6) was measured with another strip lot 43065200 with native urine.The retention material and the customer material showed no false positive results and fulfilled the requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.One customer analyzer urisys 1100 analyzer international, serial number (b)(6) and combur 10 test strips of lot 41516501 were received for investigation.The test strips were received in a zip bag instead of the original desiccant stopper vial.The test strips show discolorations.The device was clean and show no damages.The retention material of lot 41516500 was measured on an cobas u411 / urisys 1800 and was checked by visual reading with native urine, a nitrite dilution series, an erythrocyte dilution series, and a leucocyte dilution series.Additionally, the customer urisys 1100 analyzer (b)(6) was measured with another strip lot 43065200 with native urine.The retention material and the customer material showed no false positive results and fulfilled the requirements.The customer test strips show signs of discoloration on leu, nit, ery, pro, ket, ubg, bil which was most probably an effect of the not properly stored test strips.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.One customer analyzer urisys 1100 analyzer international, serial number (b)(6) was received for investigation.The meter and trays are clean and show no damages.The retention material of lot 39009500 and 39664800 were measured on a cobas u411 / urisys 1800 with native urine and a nitrite dilution series.The retention material of lot 39009500 and 39664800 were checked by visual reading with native urine and a nitrite dilution series.Additionally, the customer urisys 1100 analyzer (b)(6) was measured with another strip lot #43065200 with native urine.The retention material and the customer urisys 1100 analyzer showed no false positive results and fulfilled the requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.One vial of combur 10 test lot 39664803 and the urisys 1100 analyzer international serial number (b)(6)were received for investigation.The test strips show no abnormalities.The customer material of lot 39664803 and the retention material of lot 39664800 were measured on a cobas u411 / urisys 1800 with and were checked by visual reading with native urine and a nitrite dilution series.Additionally, the customer urisys 1100 analyzer (b)(6) was measured with another strip lot #43065200 with native urine.The retention material and the customer material showed no false positive results and fulfilled the requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.One customer analyzer urisys 1100 analyzer international, serial number (b)(6) was received for investigation.The device is clean and shows no damages.The retention material of lot 41515900 was measured on a u411/urisys 1800 analyzer and was checked by visual reading with native urine and a nitrite dilution series.Additionally, the customer urisys 1100 analyzer (b)(6) was measured with another strip lot #43065200 with native urine.The retention material and the customer material showed no false positive results and fulfilled the requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.The customer analyzer urisys 1100 analyzer international, serial number (b)(6), was received for investigation.The device was clean but showed a damaged (broken) display.Because the display of the customer analyzer does not work, the analyzer could not be investigated.One vial of combur 10 test ux 100t was also received for investigation.The material showed no abnormalities.The customer material of lot 38055502 and the retention material of lot 38055500 were both measured on a cobas u411 / urisys 1800 and were checked by visual reading with native urine and a nitrite dilution series.The retention material and the customer material showed no false positive results and fulfilled the requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.The customer's urisys 1100 analyzer serial number (b)(6) was received for investigation.The device was clean and showed no damages.Because the complained test strip lot number is unknown,, the customer urisys 1100 analyzer was measured with strip lot #43065200 with native urine.The testing material showed no false positive results and fulfilled the requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.The customer's urisys 1100 analyzer international serial number (b)(6) was received for investigation.The device was clean and showed no damages.The retention material of lot 39009700 was measured on an u411/urisys 1800 analyzer and checked by visual reading with native urine and a nitrite dilution series.The customer urisys 1100 analyzer (b)(6) was measured with another strip lot #43065200 with native urine.The retention material and the customer material showed no false positive results and fulfilled the requirements.For one other of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.The urisys 1100 analyzer serial number (b)(6) was received for investigation.The device was clean and showed no damages.Because the complained test strip lot number was unknown, the customer urisys 1100 analyzer was measured with strip lot #43065200 with native urine.The testing material showed no false positive results and fulfilled the requirements.
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Manufacturer Narrative
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For 1 of the pending events, further investigations of the device determined there were traces of an unknown liquid inside the device, causing the issue.The issue was caused by an operator mishandling.For 1 of the pending events, instrument (serial number (b)(6)) was investigated further as it wouldn't turn on when connected to the power supply.The instrument was opened and visually checked.The interior of the instrument showed traces of an unknown liquid causing the issue.The power issue was caused by operator mishandling.For 1 of the pending events, the urisys instrument serial number was provided ((b)(6) ).The instrument was returned along with test strip lot 39284003.The test strip tray on the instrument was dirty; the test strips showed no abnormalities.The customer material of lot 39284003 and the retention material were both measured on the customer's urisys 1100 analyzer ((b)(6) ) and an iu urisys 1100 analyzer and were tested by visual reading with native urine and a nitrite dilution series.The retention material of lot 39284000 was also measured on an iu urisys 1100 analyzer, the customer urisys 1100 analyzer ((b)(6) ) with artificial urine, native urine and a nitrite dilution series.The sample series was also measured on an iu cobas u411/urisys 1800 analyzer with combur 10 m/ux lot 43065200 for verification.The customer material and the retention material showed no abnormalities by visual reading and fulfill the requirements.The customer urisys 1100 analyzer showed false positive results with customer material and retention material with 0 native urine and 0 artificial urine.Further investigations of the customer analyzer shows pollution inside the device on the printed circuit board (pcb), on the bottom of the lower housing and a broken magnetic reel adheres at the upper housing.Traces of unknown liquid was found inside the device causing the problem.This was caused by operator mishandling.For 1 of the pending events, the investigation could not identify a product problem.The cause of the event could not be determined.For 1 of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions: the customer returned urisys instrument serial number (b)(6) with a test strip tray.The instrument was clean and showed no damage.The retention material of lot 41516700 was measured on an iu cobas u411 / urisys 1800 and was checked by visual reading with native urine, a nitrite dilution series and a erythrocytes dilution series.The customer's meter was also measured with another strip lot #43065200 with native urine.The retention material and the customer material showed no false positive results and fulfill the requirements.For 1 of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions: two urisys 1100 analyzers serial number (b)(6) and (b)(6) were received for investigation.The devices are clean and show no damages.One vial of combur 10 test ux lot 39664901 with 27 of 100 test strips was received for investigation.The received material showed no signs of abnormalities.The retention material of lot 39664900 was measured on a cobas u411 / urisys 1800 with native urine and a nitrite dilution series.The customer material of lot 39664901 was measured on a cobas u411 / urisys 1800 with native urine and a nitrite dilution series.The retention material and the customer material were checked by visual reading with native urine and a nitrite dilution series.Additionally, the customer urisys 1100 analyzers were measured with another strip lot #43065200 with native urine.The retention material and the customer material showed no false positive results and fulfill the requirements.For one of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions: two customer urisys 1100 analyzers serial numbers (b)(6) and (b)(6) ,were received for investigation.The devices were clean and showed no damages.The retention material of lot 36255000 was measured on a cobas u411 / urisys 1800 and was checked by visual reading with native and a nitrite dilution series.The retention material of lot 39009500 was measured on a cobas u411 / urisys 1800 and was checked by visual reading with native urine, a protein dilution series, an urobilinogen dilution series and a nitrite dilution series.The customer urisys 1100 analyzers were measured with another strip lot #43065200 with native urine.The retention material showed no false positive results and fulfilled the requirements.For one of the pending events, the customer's products have been requested for return.The product has not been received.The investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions: the retention material of lot 41516500 was measured on a cobas u411 / urisys 1800 and was checked by visual reading with native urine, a erythrocytes dilution series, a leukocytes dilution series, a ketone dilution series, a protein dilution series, and a nitrite dilution series.The retention material of lot 41516700 was measured on a cobas u411 / urisys 1800 and was checked by visual reading with native urine, a erythrocytes dilution series, a leukocytes dilution series, a ketone dilution series, a protein dilution series and a nitrite dilution series.The retention material showed no false positive or false negative results and fulfilled the requirements.For one of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions: the customer's urisys 1100 analyzer and test strips were provided for investigation.The analyzer is clean and showed no damages.The retention material of lot 39009500 and the customer material of lot 39009502 were both measured on a retention u411/urisys 1800 analyzer and were checked by visual reading with a nitrite dilution series, a leukocytes dilution series, a protein dilution series, a ketone dilution series, an erythrocytes dilution series and native urine.The measurements showed no abnormalities.The customer's urisys 1100 analyzer would not start.The analyzer was opened and a plug was found to be unplugged.The plug was plugged back in and then it was possible to start the analyzer.The customer's urisys 1100 analyzer was measured with another strip lot (43065200) with native urine.The customer material and retention material fulfilled requirements.For one of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions: the customer's analyzer urisys 1100 analyzer was received for investigation.The device is clean and shows no damages.One test strip vial of lot 39009502 and one test strip vial of lot 39664803 were received for investigation.The material shows no abnormalities.The customer material and retention material showed no false positive results on cobas u411/urisys 1800 analyzer.With a visual reading, the customer as well as retention material showed no false positive results and fulfill our requirements.The customer urisys 1100 analyzer showed no false positive results and fulfill the requirements.
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Manufacturer Narrative
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For one of the pending events, the investigation determined the issue was due to the age of the instrument.The customer returned the analyzer (b)(6) and test strip lot 40758902.The test strips showed no abnormalities.The device was clean on the outside; the printer cover was broken.The retention material and customer material were checked by visual reading with native urine, leukocytes dilution series, protein dilution series, blood dilution series, a ketone dilution series, and a nitrite dilution series.The customer material of lot 40758902 was measured on a cobas u411 / urisys 1800 with native urine.The retention material of lot 40758900 was measured on a cobas u411 / urisys 1800 with native urine, biorad lv1 #67251, quantimetrix dipper lv 1 # 44871, and quantimetrix dipper lv 2 #44872.Additionally, the test strip lot 43065200 was measured on the customer urisys 1100 analyzer (b)(6) and an urisys 1100 analyzer with native urine, biorad liquickeck# 67251, quantimetrix dipper lv 1 #44871, and quantimetrix dipper lv 2 #44872.The retention material showed no false-positive results and fulfill the requirements.The customer's test strips showed no false-positive results and fulfill the requirements.The customer's analyzer showed 20% false-positive results biorad liquichek level 1.For one of the pending events, the investigation could not identify a product problem.The cause of the event could not be determined follow up actions for this event include: one vial of test strip lot 38055401 containing 33 of 100 test strips was returned for investigation.The desiccant stopper of the customer test strip vial was damaged and the desiccant leaked out.There was no discoloration of the test strips.The customer's urisys 1100 analyzer, including the test strip tray was returned for investigation.The device was received polluted.The customer material of lot 38055401 and the retention material of lot 38055400 were both measured on a retention cobas u411 / urisys 1800 and were visually tested with native urine, a ketone dilution series, a leucocytes dilution series, and a nitrite dilution series.Additionally, the customer's urisys 1100 analyzer was measured with another strip lot #43065200 with native urine.The led intensity of the customer's analyzer was checked.Only 25% of the original desiccant was enclosed in the vial returned by the customer.Visual reading: the customer as well as retention material showed no false-positive results and fulfilled requirements.The retention material showed no false-positive results on cobas u411/urisys 1800 analyzer.The customer material showed false-positive results on cobas u411/urisys 1800 analyzer with leukocytes.It cannot be excluded that this is an effect of the leaked out, respectively decreased amount of desiccant.The customer urisys 1100 analyzer showed no false-positive results.The customer urisys 1100 analyzer fulfilled requirements.The intensity of the green led is slightly lower compared to reference meters.
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Search Alerts/Recalls
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