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

Model Number U 601

Device Problems Optical Problem (3001); Missing Test Results (3267)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2023

Event Type  malfunction  

Manufacturer Narrative

The field service engineer checked 'flowcontrol' and other files from the problem report and found no missed tubes or erroneous rack barcodes.Mechanical adjustments of tube, rack sensors and rack reading positions were okay.The root cause of the complained phenomenon was that the u601 urine analyzer did not recognize one of the racks barcode but the connected u701 urine analyzer did and this caused the sample mismatch.In case the rack barcode can not be read by one of the instruments, a shift may happen with the results.In case the customer uses the system in sequence mode, they need to monitor the results/sample mismatch very often.It is very much advised to upgrade to version 2.3.8.Of the software (the latest version).The issue is solved in software version 2.3.8.

Event Description

The customer alleged sample mismatch while working in a sequence mode without barcodes on the cobas 6500 u601 urine analyzer using software version v2.3.7.The customer started routine testing with a sample identified as n1 and rack number: 0001 so that tubes identified as n6-n10 went to rack number: 0002, tubes identified as n11-n15 to rack number: 0003, tubes identified as n16-n20 to rack number: 0004, and tubes identified as n21-n25 were expected to go to rack number: 0005, but a mismatch occurred.The sample identified as n25 was in position 3 of the rack and a sample identified as n27 was in position 4.As a result, all other numbers were shifted.

Manufacturer Narrative

The device, evaluation method, evaluation result and evaluation conclusion codes were updated.

• 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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16648489
• MDR Text Key: 312943170
• Report Number: 1823260-2023-01017
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 04015630932443
• UDI-Public: 04015630932443
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K012397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/30/2023
• Supplement Dates Manufacturer Received: 04/05/2023
• Supplement Dates FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1