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

Catalog Number	06390498001
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas u pack urine test strips lot number used was 86552500 with an expiration date of 30-apr-2026.The qc obtained expected results.The investigation is ongoing.
Event or Problem Description
We received an allegation about a questionable negative result not corresponding to the clinical picture for 1 patient tested with cobas u pack urine test strip on a cobas u 601 urine analyzer.The sample was tested on the cobas u 601 urine analyzer and obtained a negative leu (leucocytes) result.The result did not match the patient's clinical diagnosis, prompting the customer to examine the sample microscopically and observe neutrophils, suggesting a positive result.No questionable result was released outside the laboratory.
Additional Manufacturer Narrative
The requested pictures and data were provided for the investigation.The investigation was performed as follows: the retention material of the cobas u pack urine test strips, lot number 86552500, was measured on a cobas u 601 urine analyzer with material of biorad liquicheck level 2, lot number 98052, and material of biorad quantify plus level 2, lot number 1002552.The retention material of the cobas u cuvette, lot number 24103600, was measured on a cobas u 701 analyzer with material of biorad liquicheck level 2, lot number 98052, and material of biorad quantify plus level 2, lot number 1002552.The investigation results were: no false negative results on the cobas u 601 urine analyzer were observed.The results for leukocytes from the cobas u 601 urine analyzer and u 701 analyzer were comparable.All measurements fulfilled the requirements.The investigation did not identify a product problem.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24221540
• Report Number: 1823260-2026-00317
• Device Sequence Number: 9366403
• Product Code: KQO
• UDI-Device Identifier: 04015630932443
• UDI-Public: 04015630932443
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K183432
• 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): 04/15/2026

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 Catalogue Number: 06390498001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male