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

Model Number U 601

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received false positive nitrite results for three patient samples tested on a cobas u 601 analyzer.It was asked, but it is not known if any incorrect results were reported outside of the laboratory.For all three samples, the nitrite results were positive.The positive values did not agree with the microscopic bacterial results and manual testing of test strips.Samples 1 and 2 were tested on (b)(6) 2020 and the third sample was tested on (b)(6) 2020.The test strip lot number was 43071100, with an expiration date of 30-sep-2020.

Manufacturer Narrative

The microscopic bacterial determination was performed on a cobas u 701 system and the investigation determined the value to be negative.The cobas u 701 system is not released for distribution in the united states.100 % correlation is not possible when comparing the cobas u 601 nitrite measurement to the microscopic bacterial determination on the u 701 as both systems use different technology.The amount of bacteria was borderline, causing the u 601 to displaying a positive nitrite value compared to the negative microscopic bacterial determination on the u 701.The investigation did not identify a product problem.

• 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: 10252001
• MDR Text Key: 202941027
• Report Number: 1823260-2020-01649
• 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: 08/19/2020

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: 06/20/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 06/20/2020
• Supplement Dates FDA Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1