MAUDE Adverse Event Report: ROCHE DIAGNOSTICS URISYS 1100; AUTOMATED URINE ANALYZER

Model Number U1100

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

For 9 events, the investigation is ongoing.For 6 events, the investigation did not identify a product problem.The cause of the event could not be determined.The follow up action for 1 event was that the customer was sent a new test strip tray.The retention material of lot 42456000 was measured on an iu cobas u411 / urisys 1800 and was checked by visual reading with 0-native- and a nitrite-dilution-series.The follow up action for 1 event was that the customer replaced the test strip tray and the issue was resolved.The follow up action for 1 event was that the instrument did not have any issues after the replacement of the test strip tray.The follow up action for 1 event was that the customer's test strips and the test strip tray from the urisys 1100 analyzer were provided for investigation.The test strip material showed no abnormalities.The tray showed no pollution and is undamaged.The customer material of lot 42456003 was measured on a retention urisys 1100 analyzer by using an retention test strip tray and the customer test strip tray with native urine.The retention material of lot 42456000 was measured on a retention cobas u411 / cobas 1800 urisys analyzer and a retention urisys 1100 analyzer by using a retention test strip tray and the customer test strip tray and was tested by visual reading with a nitrite dilution series, and native urine.No false positive results observed, neither with the retention test strip tray, nor with the customer test strip tray.The follow up action for 1 event was that the retention material of lot 42456000 was measured by visual reading with a nitrite dilution series and native urine.The retention material fulfilled the requirements.No false positive results observed.The follow up action for 1 event was that the customer analyzer urisys 1100 analyzer was received for investigation.The device is clean and shows no damages outside.One vial of combur10 test strips was received for investigation.Test strips show no abnormalities.The retention material of lot 41516700 and the customer material of lot 41516702 were measured on a cobas u411 / urisys 1800 with native urine and a nitrite dilution series.The retention material of lot 41516700 and the customer material of lot 41516702 were checked by visual function 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.The follow up action for 1 event was that the retention material of lot 41516700 was measured on a cobas u411 / urisys 1800 with native urine and a nitrite dilution series.The retention materials of lot 41516700 was visually checked and measured with native urine and a nitrite dilution series.The retention material showed no abnormalities.The follow up action for 1 event was that the customer was sent a new test strip tray.The follow up action for 1 event was that the urisys 1100 analyzer was received for investigation.The analyzer showed no damages outside, but massive signs of pollution inside the printer compartment.The display of the analyzer did not work.Analyzer was opened and showed massive signs of pollution inside the analyzer.There were no follow up actions for 6 events.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 continued: (b)(4).

Event Description

This report summarizes 15 malfunction events.Questionable false positive results were generated by the urisys 1100 analyzer.The events involved a total of at least 15 patients.For each event, the customer only said "several" patients had questionable results for nitrite.

Manufacturer Narrative

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 include: the test strip tray was replaced and the issue was resolved after this.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: the customer had no further issues after receiving the new test strip tray.The old test strip tray is no longer available for investigation.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: the customer's instrument, test strips, and test strip tray were requested but no product was returned.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: the retention material of lot 39664800 was measured on a cobas u411 / urisys 1800 and were checked by visual reading with native urine and a nitrite dilution series.The retention material of the additional claimed lot 43799600 was checked by visual reading with native urine and a nitrite dilution series.Additionally, the customer urisys 1100 analyzer ux09657182 was measured with another strip lot #43065200 with native urine.The retention material and the customer meter showed no false-positive results and fulfill the requirements.The customer's test strips were requested but not returned.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: the customer returned the analyzer s/n ux09659768, with software-version 5.71, including test strip tray c5.The device is clean and showed no external damage.The customer also returned strip lot 42456003.The retention material of lot 42456000 and the customer material of lot 42456003 were measured on a cobas u411 / urisys 1800 and was checked by visual reading with native and a nitrite dilution series.The customer's urisys 1100 analyzer ux09659768 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 customer's analyzer fulfills 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.Follow up actions for this event include: the retention material of lot 39664900 was measured on a retention urisys 1800 /cobas u411 analyzer and was visually tested with native urine and a nitrite dilution series.The retention material shows no false-positive results and fulfills 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.Follow up actions for this event include: the customer analyzer urisys 1100 was received for investigation without the test strip tray.The device was clean and shows no damages.Additionally, the customer device was measured with retention material of 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 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 7 test strip trays were provided for investigation.The analyzer was clean and showed no damages on the outside.One test strip tray showed massive signs of pollution.One other test strip tray was polluted, three had no signs of pollution, and two were sealed in original packaging.One vial of test strip lot 39664803 with 33 remaining test strips was also provided for investigation.All test strips showed no abnormalities.The retention material and the customer material of lot 396648 were measured on a retention cobas u411 / urisys 1800 with native urine and a nitrite dilution series.The customer material and retention material were 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 with 5 of the provided trays.Two trays were not measured because they were originally sealed.The retention material and the customer material showed no false-positive results and fulfilled requirements.

• Brand Name: URISYS 1100
• Type of Device: AUTOMATED URINE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis, in
• MDR Report Key: 10331936
• MDR Text Key: 202070486
• Report Number: 1823260-2020-90116
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Number of Events Reported: 15
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: U1100
• Device Lot Number: UX09637730, UX09638640
• Patient Sequence Number: 1