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

Model Number	U1100
Medical Device Problem Codes	False Negative Result (1225); False Positive Result (1227); High Readings (2459); Low Readings (2460)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: AUTOMATED URINE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 10749742
• Report Number: 1823260-2020-90158
• Device Sequence Number: 17063911
• Product Code: KQO
• UDI-Device Identifier: 00075537253564
• UDI-Public: 00075537253564
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• 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
• Operator of Device: No Information
• Device Model Number: U1100
• Device Catalogue Number: 3617556001
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2020
• Patient Sequence Number: 1