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

Model Number	U 601
Medical Device Problem Codes	Optical Problem (3001); Missing Test Results (3267)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
The device, evaluation method, evaluation result and evaluation conclusion codes were updated.

• Brand Name: COBAS U 601 URINE ANALYZER
• Common Device Name: 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
• Report Number: 1823260-2023-01017
• Device Sequence Number: 12274124
• Product Code: JIL
• UDI-Device Identifier: 04015630932443
• UDI-Public: 04015630932443
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K012397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: U 601
• Device Catalogue Number: 06390498001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown