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 this event, the investigation did not identify a product problem.The cause of the event could not be determined.Follow up actions for this event include: retention material from the same lot 39664803 has been tested and no issue has been found for this material.Therefore, a product problem with the strips is unlikely.Qc samples performed as expected during this time frame.Therefore, a general instrument performance issue is unlikely.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 1 malfunction event.Questionable false negative nitrite results were generated by a urisys 1100 analyzer.The event involved three patient samples.The patients' ages were requested, but were not provided.The patients' ages 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.

• Brand Name: URISYS 1100
• Type of Device: AUTOMATED URINE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis, in
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; mannheim (baden-wurttemberg), 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; indianapolis, in
• MDR Report Key: 9996216
• MDR Text Key: 221234853
• Report Number: 1823260-2020-90060
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: U1100
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2020
• Type of Device Usage: N
• Patient Sequence Number: 1