MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS U 601 URINE ANALYZER; AUTOMATED URINE ANALYZER

Model Number U 601

Device Problem Low Test Results (2458)

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

Event Type  malfunction  

Manufacturer Narrative

The investigations found for the 1 event that the investigation is ongoing.The summary of the investigation results are not yet available.The follow up/corrective actions for the 1 event is not yet available.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.An erroneous low result was generated by the cobas u 601 urine analyzer the events involved a total of 1 patient with the following: a false negative bacteria result.

Manufacturer Narrative

The customer has not returned any product.The investigation performed retention testing on the strip lot involved (37318500).Retention material showed no abnormalities and no false negative results.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS U 601 URINE ANALYZER
• Type of Device: AUTOMATED URINE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8549744
• MDR Text Key: 143408552
• Report Number: 1823260-2019-90088
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 04015630932443
• UDI-Public: 04015630932443
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: U 601
• Patient Sequence Number: 1