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

Model Number U1100

Device Problem Non Reproducible Results (4029)

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

Event Type  malfunction  

Manufacturer Narrative

The investigations of both events are ongoing.For one event, follow up actions include: the customer was sent a new test strip tray.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.Non reproducible nitrite, erythrocyte, and leukocyte results for an unspecified number of patient samples were generated by urisys 1100 analyzers.

Manufacturer Narrative

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) ) with a test strip tray.The device was clean and showed no damage.The retention material of lot 41515900 was measured on an iu cobas u411 / urisys 1800 and visually checked with native urine, blood dilution series, a leucocytes dilution series and a nitrite dilution series.The customer's 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 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 for this event: the reporter's urisys 1100 analyzer was returned for investigation.The device is clean and shows no damages.The reporter's test strips were also returned for investigation.The test strips showed no abnormalities.The customer material and retention material of lot 396648 were measured on a retention cobas u411 / urisys 1800 and visually checked with native urine, a ketone dilution series, a leucocytes dilution series, an erythrocytes dilution series, a protein dilution series, a glucose dilution series and a nitrite dilution series.Additionally, the customer's analyzer 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.

• Brand Name: URISYS 1100
• Type of Device: AUTOMATED URINE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis, in
• MDR Report Key: 9996178
• MDR Text Key: 221519933
• Report Number: 1823260-2020-90063
• 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: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: U1100
• Patient Sequence Number: 1