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

Model Number U1100

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Manufacturer Narrative

For 2 events, the investigation is ongoing.The follow up action for 1 event was that the retention material of lot 42220100 was visually checked.The retention material shows no abnormalities and no signs of discolorations.The retention material fulfills the requirements.There were no follow up actions for 1 event.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.

Event Description

This report summarizes 2 malfunction events.Questionable false negative results were generated by the urisys 1100 analyzer.The events involved a total of 5 patients with the following: 5 questionable nitrite results.The patients' ages ranged from 24 years to 37 years.The other patients' ages were requested, but were not provided.The patients' weights ranged from 116 to 250 lbs.The other patients' weights were requested, but were not provided.There were 4 females.The other 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 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 following: the reporter's urisys 1100 was provided for investigation.The device was clean and showed no damages.The retention material of lot 42456000 and 41517000 were both measured on a retention cobas u411/urisys 1800 analyzer and on the received urisys 1100 analyzer with a nitrite dilution series, a protein dilution series, a leukocytes dilution series, and native urine.The test strip retention material was also tested by visual reading with a nitrite dilution series, a protein dilution series, a leukocytes dilution series, and native urine.The retention material showed no false-negative results and fulfilled 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 following: one vial of chemstrip 10md lot 42220105 containing 91 of 100 test strips and one urisys 1100 analyzer serial number (b)(6) was received for investigation.The test strips show no abnormalities and the test strip tray of the device showed signs of corrosion and light pollution.The customer material of lot 42220105 was measured on a cobas u411 / urisys 1800 with native urine and a nitrite dilution series and on an urisys 1100 and customer analyzer with native urine and a nitrite dilution series.The customer material fulfilled the requirements and no false-negative results observed.

• Brand Name: URISYS 1100
• Type of Device: AUTOMATED URINE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis, in
• MDR Report Key: 10331932
• MDR Text Key: 202530321
• Report Number: 1823260-2020-90117
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Number of Events Reported: 2
• 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: UX09657274, UX09663003
• Patient Sequence Number: 1