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

Model Number U 601

Device Problem Computer Software Problem (1112)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2019

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6).

Event Description

The initial reporter complained of a software issue on a cobas u 601 urine analyzer with software version 2.2.7 which could impact patient results, interpretation of patient results, or patient identification.The customer stated that the same patient identification for the same sample rack and position was used for two different patient results ran at different times.The customer stated that the same sample was not rerun.At 16:11 the results from the u 601 were color was pale yellow, clarity was clear, ph was 7, specific gravity was 1.031, nitrate was negative, protein was negative, glucose was 4+, ketone was negative, urobilinogen was negative, bilirubin was negative, erythrocytes were negative, and leukocytes were 3+.At 16:38 the results from the cobas u 601 for the same sample identification from the same sample rack and position were color was pale yellow, clarity was clear, ph was 6.5, specific gravity was 1.012, nitrate was negative, protein was negative, glucose was negative, ketone was negative, urobilinogen was negative, bilirubin was negative, erythrocytes were negative, and leukocytes were negative.No questionable results were reported outside of the laboratory.There was no allegation of an adverse event.No reagent lot numbers or expiration dates were provided.

Manufacturer Narrative

The issue has not reoccurred at the customer's site.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 0457
• MDR Report Key: 8817965
• MDR Text Key: 152061507
• Report Number: 1823260-2019-02669
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• PMA/PMN Number: K012397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: U 601
• Device Catalogue Number: 06390498001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/29/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 06/29/2019
• Supplement Dates FDA Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1