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

Model Number U1100

Device Problems False Negative Result (1225); False Positive Result (1227); High Readings (2459); Low Readings (2460)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.The follow up actions were the customer cleaned the meter's tray, the "chip" was removed and re-inserted, and the meter was calibrated and restarted.The issue still persisted.The customer confirmed the dry test strip pads and reference pads had no discoloration, damage, or were soiled.The customer's meter was returned for investigation, and a new meter was sent to the customer.Control tests for levels 1 and 2 were performed on the meter and the results passed for all tests including leukocytes and nitrites.After the customer's meter was replaced, no complaints were reported.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

The initial reporter received questionable false negative and false positive leukocyte results for "8 or 9 patients" with chemstrip 10 md test strips on a urisys 1100 analyzer.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.

• Brand Name: URISYS 1100
• Type of Device: AUTOMATED URINE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; mannheim (baden-wurttemberg), 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 10749742
• MDR Text Key: 242855876
• Report Number: 1823260-2020-90158
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 00075537253564
• UDI-Public: 00075537253564
• 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
• Device Catalogue Number: 3617556001
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2020
• Type of Device Usage: N
• Patient Sequence Number: 1