| 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 28 events, the investigations could not identify a product problem.The cause of these events could not be determined.For 3 events, the investigations could not identify a product problem.The cause of the events could not be determined.The devices were not returned for investigation.For 13 events, the investigations are ongoing.There were no follow up actions for two events.Follow up actions for one event include: the customer's remaining test strips and urisys 1100 analyzer were provided for investigation.The test strips showed no abnormalities.The analyzer and tray were clean.The customer material and retention material of lot 380553 were measured on a retention cobas u411 / urisys 1800 with native urine, an erythrocyte dilution series, a leukocyte dilution series and a nitrite dilution series.The retention material and customer material were checked by visual reading with native urine, a leukocyte dilution series and a nitrite dilution series.Additionally, the customer urisys 1100 analyzer ux0965754 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.Follow up actions for seven events include: the test strip tray was replaced and the analyzer had no further issues after this.Follow up actions for two events include: the customer was sent a new test strip tray.Follow up actions for two events include: the customer was sent a new test strip tray, but this did not resolve the issue.Follow up actions for one event include: the retention material of lot 41516700 was checked by visual reading and on a retention urisys 1800/u411 with native urine and a nitrite dilution series.The retention material showed no false positive results and fulfilled requirements.Follow up actions for one event include: retention material of test strip lot 43065200 was tested and was acceptable.Follow up actions for one event include: the customer's analyzer urisys 1100 analyzer international serial number (b)(4) was received for investigation.The device was clean and shows no damages.The retention material of test strip lot # 41515900 was checked by visual reading and on a urisys 1800/ cobas u411 with native urine and a nitrite dissolution series.The customer urisys 1100 analyzer was measured with another strip lot #43065200 with native urine.The customer material showed no false positive results and fulfilled the requirements.Follow up actions for one event include: the customer material of test strip lot 39009502 and 41515903 were measured on a cobas u411 / urisys 1800 with native urine and a nitrite dilution series.The retention material of lot 39009500 and 41515900 were 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's urisys 1100 analyzer serial number (b)(4) 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.Follow up actions for one event include: the meter and test strips were returned for investigation.The customer material of test strip lot 39664803 was measured on a retention cobas u411 / urisys 1800 with 0-native-urine, a nitrite-dilution-series, a leukocytes-dilution-series and an erythrocyte dilution-series.The retention material of lot 39664800 was measured on a retention urisys 1800 / cobas u411 with 0-native urine and a nitrite-dilution-series, an erythrocytes-dilution-series and a leucocytes-dilution-series.The retention material and customer material were checked by visual reading with 0-native-urine, a nitrite-dilution-series, a leukocytes-dilution-series and an erythrocyte dilution-series.Additionally, the customer urisys 1100 analyzer ux09654002 was measured with another strip lot #43065200 with 0-native urine.The retention material and the customer material showed no false positive results and fulfills our requirements.Follow up actions for one event include: the customer was sent a new test strip tray.The customer returned the analyzer with a test strip tray.The analyzer was clean and showed no damage.The retention material of test strip lot 36255000 was checked by visual reading and on a retention urisys 1800/ cobas u411 with 0-native urine and a nitrite- dissolution-series.The customer's analyzer was measured with another strip lot 43065200 with 0-native urine.The customer material showed no false positive results and fulfill the requirements.Follow up actions for one event include: the customer's urisys 1100 analyzer and test strips were provided for investigation.The analyzer is clean and showed no damages.The customer test strip material of lot 40758902 and the retention material of lot 40758900 were both visually checked.The customer test strip material showed discolorations on the nitrite and protein test pads.The retention material shows no abnormalities.Follow up actions for one event include: the customer returned the analyzer with a test strip tray.The analyzer was clean and showed no damage.The retention material of test strip lot 40758900 was measured on a retention cobas u411 / urisys 1800 and was checked by visual reading with 0-native-urine and a nitrite-dilution-series.The customer's analyzer was measured with another strip lot 43065200 with 0-native urine.The customer material showed no false positive results and fulfill the requirements.Follow up actions for one event include: the customer was sent a new test strip tray.The customer returned meter serial number (b)(4) with a test strip tray.The device was clean and showed no damage.The retention material of test strip lot 39009500 was measured on a retention cobas u411 / urisys 1800 with 0-native-urine and a nitrite-dilution-series.The retention material was checked by visual reading with 0-native-urine and a nitrite-dilution-series.Additionally, the customer's urisys 1100 analyzer ux09651560 was measured with another strip lot 43065200 with 0-native urine.The retention material and the customer material showed no false positive results and fulfill the requirements.Follow up actions for one event include: the customer's analyzer urisys 1100 analyzer serial number (b)(4) was received for investigation.The device was clean and showed no damages.One vial of combur 10 test lot# 41515903 was also received for investigation.The material showed no abnormalities.The customer material of lot # 41515903 was checked by visual reading and on a urisys 1800/ cobas u411 with native urine and a nitrite dissolution series.The retention material of lot # 41515900 was checked by visual reading and on a urisys 1800/ cobas u411 with native urine and a nitrite dissolution series.The customer urisys 1100 analyzer ux09644325 was measured with another strip lot #43065200 with native urine.The customer material showed no false positive results and fulfilled the requirements.Follow up actions for one event include: the retention material of lot 41515900 was measured on a cobas u411 /urisys 1800 with native urine and a nitrite dilution series.The retention material showed no false positive results and fulfilled requirements.Follow up actions for one event include: the customer's urisys 1100 analyzer was provided for investigation.The device is clean and showed no damages.The customer's urisys 1100 analyzer was measured with another strip lot (43065200) with native urine.The customer material showed no false positive results and fulfilled requirements.Follow up actions for one event include: the customer tried using a new test strip tray, but the problem was not solved.The analyzer was returned with a test strip tray.The device was clean and showed no damage.The customer's instrument was measured with another strip lot 43065200 with 0-native urine.The retention material of lot 3664800 and 39009500 were measured on an iu cobas u411 / urisys 1800 and were checked by visual reading with 0-native-urine and a nitrite-dilution-series.The retention material of lot 41516700 measured on an iu cobas u411 / urisys 1800 and was checked by visual reading with 0-native-urine and a nitrite-dilution-series.The customer material showed no false positive results and fulfill the requirements.Follow up actions for one event include: none of investigated lots from combur10 ux could be confirmed to produce false positive results for nit.Follow up actions for one event include: the reporter's urisys 1100 analyzer was provided for investigation.The device was clean and showed no damages.The reporter's analyzer was tested using another test strip lot (43065200) with native urine.The customer material showed no false positive results and fulfilled requirements.Follow up actions for one event include: the customer was sent a new test strip tray, however, the problem was not solved.The meter was requested for investigation.Follow up actions for one event include: the customer was sent a new test strip tray.The customer returned the analyzer with a test strip tray and one vial of strip lot 40396202 and one vial of strip lot 41515903.The analyzer was clean and showed no damage.The retention material of lot 41515900 was checked by visual reading and on iu urisys 1800/ cobas u411 with 0-native urine and a nitrite-dilution-series.The customer material of lot 41515903 was checked by visual reading and on iu urisys 1800/ cobas u411 with 0-native urine and a nitrite-dilution-series.The retention material of lot 40396200 was checked by visual reading and on iu urisys 1800/ cobas u411 with 0-native urine and a nitrite-dilution-series.The customer material of lot 40396202 was checked by visual reading and on iu urisys 1800/ cobas u411 with 0-native urine and a nitrite-dilution-series.The customer's analyzer was measured with another strip lot 43065200 with 0-native urine.The customer material showed no false positive results and fulfill the requirements.Follow up actions for one event include: the test strip tray was changed and the situation improved.Follow up actions for one event include: the customer replaced the test strip tray, but the issue remained.The customer analyzer urisys 1100 analyzer serial number (b)(4), was received for investigation.The device was clean and showed no damages.One vial of combur 10 test ux lot 41515903 was also received for investigation.The cardboard disc had fallen out of the lid and also the desiccant leaked out of the vial lid.The test strips show no abnormalities.The retention material of lot 41515900 and the customer material of lot 41515903 were both measured on a cobas u411 / urisys 1800 and were checked by visual reading with native urine and a nitrite dilution series.Additionally, the customer urisys 1100 analyzer ux09659363 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.Follow up actions for one event include: one customer analyzer urisys 1100 analyzer serial number (b)(4) was received for investigation.The device is clean and shows no damages.The customer urisys 1100 analyzer was measured with another strip lot #43065200 with native urine.The customer material showed no false positive results and fulfilled the requirements.Follow up actions for one event include: the customer tried taking out the reference pad to clean the test strip tray.After doing this, there were no further issues.Follow up actions for one event include: the test strip tray was very old and was replaced.The new test strip tray did not resolve the issue.Follow up actions for one event include: the test strip tray and reference pad were checked and no abnormalities were seen.Controls were also tested.The retention material of the same lot (41515903) was measured on a retention cobas u411 / urisys 1800 with native urine, a ketone dilution series, and a leukocytes and a blood dilution series.The retention material was checked by visual reading with native urine, a ketone dilution series, and a leukocytes and a blood dilution series.The retention material showed no false positive results and fulfilled requirements.Follow up actions for one event include: the retention material of test strip lot 41515900 was checked by visual reading and on a retention urisys 1800/ cobas u411 with native urine and a nitrite dilution series.The customer urisys 1100 analyzer ux09650624 was measured with another strip lot (43065200) with native urine.The customer material showed no false positive results and fulfilled requirements.Follow up actions for one event include: the customer's urisys 1100 analyzer and one vial of test strip lot 41515903 were provided for investigation.The analyzer was slightly contaminated and showed no damages.The test strip material showed no abnormalities.The retention material of test strip lot 41515900 was measured visually and on retention urisys 1800/u411 with native urine and a nitrite dilution series.The customer material of test strip lot 41515903 was measured visually and on retention urisys 1800/u411 with native urine and a nitrite dilution series.The customer urisys 1100 analyzer ux09650261 was measured with another strip lot (43065200) with native urine.The customer material showed no false positive results and fulfilled requirements.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 numbers cont'd: (b)(4).
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Event Description
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This report summarizes 44 malfunction events.Questionable false positive nitrite results were generated by urisys 1100 analyzers the events involved an unspecified number of patient samples.One patient's age was (b)(6).The remaining patients' ages were requested, but were not provided.The patients' weights were requested, but were not provided.One patient is male.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 1 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: the customer's analyzer and test strips were provided for investigation.The device is clean and showed no damages.The test strips showed no abnormalities.The customer material of lot 39664804 and retention material of the same lot were measured on a retention cobas u411 / urisys 1800 and visually checked with native urine, a leucocyte dilution series and a nitrite dilution series.Additionally, the customer urisys 1100 analyzer ux09641568 was measured with another strip lot (43065200) with native urine.The retention material and the customer material showed no false positive or negative results and fulfilled 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: the customer returned the instrument (serial number (b)(6) ) and test strips lot 41515903.The device was clean and showed no damage.The test strips showed no abnormalities.The customer material of lot 41515903 was measured on an iu cobas u411 / urisys 1800 and visually checked with native urine and a nitrite dilution series.The retention material of lot 41515900 was measured on an iu cobas u411 / urisys 1800 and visually checked with native urine and a nitrite dilution series.The customer urisys 1100 analyzer ux09643081 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 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 the instrument (serial number (b)(6) ) and test strip lot 40759401.The instrument was clean and showed no damage.The test strips showed no abnormalities.The vial was open when the material arrived.The retention material of lot 40759400 was measured visually and on iu urisys 1800/u411 with native urine, a leucocytes dissolution series, a protein dissolution series, a glucose dissolution series, a ketone dissolution series, a blood dissolution series and a nitrite dissolution series.The customer material of lot 40759401 was measured visually and on iu urisys 1800/u411 with native urine, a leucocytes dilution series, a protein dissolution series, a glucose dissolution series, a ketone dissolution series, a blood dissolution series and a nitrite dissolution series.The customer's instrument (ux09656334) was measured with another strip lot 43065200 with native urine.The retention material and the customer material showed no false positive or not reproducible results and fulfill the requirements.For 1 of the pending events, for one of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.For 1 of the pending events, or 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: one customer analyzer urisys 1100 analyzer serial number (b)(6) was received for investigation.The device is clean and show no damages.One vial of combur 10 ux lot# 41516702, received for investigation.The material show no abnormalities.The retention material of lot # 41516700 was measured visually and on an urisys 1800/u411 with native urine, a leucocytes dissolution series and a nitrite dissolution series.The customer material of lot # 41516702 was measured visually and on an urisys 1800/u411 with native urine, a leucocytes dissolution series and a nitrite dissolution series.The customer urisys 1100 analyzer ux09659246 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 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 for this event include: the customer's urisys 1100 analyzer was provided for investigation.The device is clean and showed no damages.The customer's test strip lot 41516703 was provided for investigation.The material showed no abnormalities.The retention and customer material of test strip lot 415167 was measured visually and on a retention urisys 1800/u411 with native urine and a nitrite dilution series.The retention material of test strip lot 39664800 was measured visually and on a retention urisys 1800/u411 with native urine and a nitrite dilution series.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 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 for this event include: the customer's urisys 1100 analyzer was provided for investigation.The device is clean and showed no damages.The retention material of test strip lot 41516700 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 1 of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.The customer returned the urisys instrument (ux09640596) and test strips lot 41516703.The customer material of lot 41516703 was measured on an iu cobas u411 / urisys 1800 and was measured by visual reading with native urine and a nitrite dilution series.The retention material of lot 41516700 and lot 39664800 were both measured on an iu cobas u411 / urisys 1800 and were measured by visual reading with native urine and a nitrite dilution series.Additionally, the customer's urisys 1100 analyzer ux09640596 was measured with another strip lot 43065200 with native urine.The retention material and the customer material showed no false positive or negative 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: one vial of combur 10 test strips lot 41515903, one vial of combur 10 test strips lot 41516703, and one vial of combur 10 test strips lot 42221401 were received for investigation.The test strips show no abnormalities.The retention material of lot 41515900 and 41516700 were measured on a cobas u411 / urisys 1800 and was checked by visual reading with native urine and a nitrite dilution series.The retention material of lot 42221400 was checked by visual reading with native urine and a nitrite dilution series.The customer material of lot 41515903 and 41516703 were measured on a 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.No abnormal coloration was observed.The materials fulfilled 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: the customer returned meter ux09656648.The retention material of lot 41516700 was measured on an iu cobas u411 / urisys 1800 and was measured by visual reading with native urine and a nitrite dilution series.Additionally, the customer urisys 1100 analyzer ux09656648 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.
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Manufacturer Narrative
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For one of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.The customer returned analyzer ux09654298 and strip lot 40758902.The analyzer was clean and showed no damage.The retention material of lot 40758900 was measured on the customer urisys 1100 analyzer s/n ux09654298, an urisys 1100 analyzer, a cobas u411/urisys 1800 analyzer and was also tested by visual reading with native urine and a nitrite dilution series.No false positive or false negative results received.The retention material showed no abnormalities.The customer analyzer showed no abnormalities.The customer's test strips showed discolored nitrite test pads.For one 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 was returned for investigation.The device is clean and shows no damages outside.The tray is dirty.One vial of combur 10 test strips containing was received.The test strips show no abnormalities.The retention material of lot 41516700 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 42456000 was measured on a cobas u411 / urisys 1800 and was checked by visual reading with native and a nitrite dilution series.The customer material of lot 41516703 was checked by visual reading with native and a nitrite dilution series.The customer material of lot 41516703 and the retention material of lot 41516700 were both measured with an urisys 1100 analyzer and the customer urisys 1100 with a nitrite dilution series and native urine.No abnormal coloration observed during the measurements for visual reading with customer material and all used retention material.The customer material and retention material fulfills the requirements for measurements with cobas u411 / urisys 1800 analyzer and urisys 1100 analyzer.The measurements on customer analyzer urisys 1100 showed no false-positive results, neither with customer nor with retention material.For one 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 5 test strips lot 38055102, containing 75 of 100 test strips was received for investigation.The material shows no abnormalities.The customer material of lot 38055102 and the retention material of lot 38055100 were both checked by visual reading with a nitrite dilution series, a leucocyte dilution series, and native urine.Both materials fulfill our requirements.No false-positive results observed.
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Search Alerts/Recalls
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