MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS U PACK (400 STRIPS); URINE TEST STRIP

Catalog Number	06334601001
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the u 601 analyzer is (b)(6).The investigation is ongoing.Medwatch field e1 initial reporter establishment name - the full name was provided as "(b)(6) hospital affiliated to (b)(6) hospital of (b)(6) university".The e1 initial reporter email address was provided as "(b)(6)".
Event or Problem Description
The initial reporter stated they received questionable negative leukocyte results for two patient samples tested with a cobas u pack on a cobas u 601 urine analyzer.No questionable results were reported outside of the laboratory.The analyzer results did not match the clinical diagnoses of the patients.The patients did not have any disease.The first sample resulted in a negative leukocyte value on the u 601 analyzer and when checked on a urine microscopy analyzer, the result was 112.20 leukocytes/ul.The sample was also tested on a second urine analyzer (cobas u 411) and the leukocyte result was 1+.A manual microscopy read of the urine sample showed many leukocytes (a specific value could not be provided).The second sample resulted in a negative leukocyte value when tested on the u 601 analyzer on (b)(6) 2025.When checked on the urine microscopy analyzer on (b)(6) 2025, the result was 87.12 leukocytes/ul.The sample was tested on the second urine analyzer on (b)(6) 2025, resulting in a 1+ leukocyte result.A manual microscopy read of the urine sample showed many leukocytes (a specific value could not be provided).
Additional Manufacturer Narrative
The investigation determined the issue is consistent with the customer modifying the range table settings of the u 601 analyzer.The u 601 analyzer provides a semi quantitative result as a range.Different systems may provide slightly different results even when repeating a measurement from the same sample.This is due to slight difference of parts like the led , detection sensor , and test strip recipe.Despite the reported discrepancy, the amount of discrepant results compared to all measurements is still acceptable according to the performance data and meet specifications.The range limit for was modified locally to make u 601 less sensitive.
Additional Manufacturer Narrative
The customer alleged that one of the two patients received treatment for a urinary tract infection.It was not specified which patient received treatment or what the specific treatment was.This patient was female.

• Brand Name: COBAS U PACK (400 STRIPS)
• Common Device Name: URINE TEST STRIP
• 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: 22902703
• Report Number: 1823260-2025-02627
• Device Sequence Number: 18346473
• Product Code: CDM
• UDI-Device Identifier: 04015630932252
• UDI-Public: 04015630932252
• 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,Followup
• Report Date (Section B): 10/06/2025

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 Expiration Date: 12/31/2025
• Device Catalogue Number: 06334601001
• Device Lot Number: 84770900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 08/29/2025; 09/23/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/19/2025; 10/06/2025
• 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 Age: 53 YR
• Patient Sex: Female