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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS URISYS 1100; AUTOMATED URINE ANALYZER
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ROCHE DIAGNOSTICS URISYS 1100; AUTOMATED URINE ANALYZER Back to Search Results
Model Number U1100
Device Problem False Positive Result (1227)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigations for all of the events are ongoing.For 1 of the events, the customer installed a new test strip tray but the problem continued.For 8 of the events, the test strip tray was replaced and there have been no further false positive nitrite results.For 1 of the events, the meter was cleaned and checked by the technician.Afterwards, the issue was resolved.For 1 of the events, the meter was replaced and the problem was resolved.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).
 
Event Description
This report summarizes 20 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 requested, but were not provided.The patients' weights were requested, but were not provided.The 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.
 
Manufacturer Narrative
For one event, the investigation determined the issue was resolved by the replacement the test strip tray.For 12 of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions: no product was returned for investigation.
 
Manufacturer Narrative
For one of the pending events, the customer returned meter serial number (b)(6).The test strips were not returned.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 customer returned meter serial number (b)(6) with no test strip tray and software chip.The meter was tested with a different strip lot (43065200) with native urine.No false positive results were obtained.The results 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.Follow up actions for this event include: a new test strip tray was installed on the analyzer, but this did not resolve the issue.Controls were tested on the meter and the results were ok.The customer's analyzer and test strips were provided for investigation.The customer material of lot 39009502 was measured on a retention cobas u411 / urisys 1800 with native urine and a nitrite dilution series.The retention material of lot 390095 was measured on a retention 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 fulfills 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 two urisys 1100 analyzers and 2 lots of remaining test strips (lots 38055502 and 39664803) from the customer were provided for investigation.The customer material showed no abnormalities.The customer and retention material of test strip lots 380555 and 396648 were measured on a retention 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 customer urisys 1100 analyzer (b)(6) was used for investigation testing, but after two runs the analyzer did not start any more measurements.No further investigation of this meter was possible.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 strip tray was slightly polluted.The retention material of lot 38055300 was measured on a retention cobas u411 / urisys 1800 with native urine, a leukocyte, protein, nitrite and a ketone dilution series.The retention materials of lot 38055300 and the customer material of lot 38055301 were visually checked and measured with native urine, a leukocyte, protein, nitrite and a ketone dilution series.Additionally, the customer analyzer was measured with another strip lot (43065200) with native urine by using the customer test strip tray and a retention tray.The retention material and the customer material showed no false positive results and fulfilled requirements.
 
Manufacturer Narrative
For one of the pending events, the investigation determined the dirt inside the meter was the root cause of the issue.The customer returned analyzer ux09630091.The instrument was very dirty inside with residual sample material and fibers.The test strip tray was also slightly dirty with residual sample material.The retention material of lot 38055300 was measured on an iu cobas u411/urisys 1800 analyzer, an iu urisys 1100 analyzer, and was visually checked with a nitrite dilution series and native urine.In addition, the customer's analyzer ux09630091 was measured with native urine by using the customer tray.The customer's device was checked regarding led intensity.The retention material showed no false-positive results and fulfilled the requirements.The customer's urisys 1100 analyzer showed 100% false-positive results with biorad liquichek level 1.The customer urisys 1100 analyzer does not fulfill the requirements.Led-intensity shows significant deviation fading due to the aging of components compared to reference devices.For one of the pending events, the specific cause of the event could not be determined.The customer returned analyzer ux09636012.The device was clean and showed no damage on the outside.Inside, the device was dirty with residual sample material.The customer's analyzer was measured with strip lot 43065200 with native urine.Some false-positive results for nitrites were received.The analyzer was further investigated to check led intensity.The green led showed a slightly lower intensity.The retention material showed no false-positive results and fulfill the requirements.For one of the pending events, the investigation could not identify a product problem.The cause of the event could not be determined.The reporter's analyzer and test strips were provided for investigation.The test strips showed no abnormalities.The device showed no damages or pollution on the outside.The test strip tray was slightly polluted.The retention material of lot 38055300 was measured on a retention cobas u411 / urisys 1800 with native urine, a leukocyte, protein, nitrite, and a ketone dilution series.The retention materials of lot 38055300 and the customer material of lot 38055301 were checked by visual reading with native urine, a leucocyte, protein, nitrite, and a ketone dilution series.Additionally, the customer analyzer urisys 1100 analyzer was measured with another strip lot #43065200 with native urine by using the customer tray.The customer's device was checked regarding led intensity.The measurements of retention material with cobas u411/ urisys 1800 showed no false-positive results.The results for visual reading fulfill requirements for both retention and customer material.No false-positive results observed.The additional measurement with the customer analyzer and customer tray shows no false-positive results.The analyzer fulfilled requirements.The intensity of the green led is slightly lower compared to reference meters.
 
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Brand Name
URISYS 1100
Type of Device
AUTOMATED URINE ANALYZER
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250
MDR Report Key9246393
MDR Text Key219403670
Report Number1823260-2019-90224
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
Number of Events Reported20
Summary Report (Y/N)Y
Report Source Manufacturer
Type of Report Initial,Followup,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberU1100
Patient Sequence Number1
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