MAUDE Adverse Event Report: ROCHE DIAGNOSTICS URIC ACID VER.2; URIC ACID TEST SYSTEM

Model Number	5171857190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 c702 module serial number was (b)(6).The customer found that the r2 reagent of the affected reagent pack had turned dark red.The suspected reagent was requested for further investigation.
Event or Problem Description
There was an allegation of questionable uric acid ver.2 results from the cobas 8000 c702 module.The customer replaced the reagent pack and performed repeat testing.Sample (b)(6), initial result was 636 umol/l, and the repeat result was 312 umol/l.Sample (b)(6), initial result was 583 umol/l, and the repeat result was 218 umol/l.Sample (b)(6), initial result was 733 umol/l, and the repeat result was 419 umol/l.Sample (b)(6), initial result was 648 umol/l, and the repeat result was 308 umol/l.Sample (b)(6), initial result was 621 umol/l, and the repeat result was 268 umol/l.Sample (b)(6), initial result was 595 umol/l, and the repeat result was 227 umol/l.Sample (b)(6) initial result was 528 umol/l, and the repeat result was 85 umol/l.Sample (b)(6), initial result was 713 umol/l, and the repeat result was 394 umol/l.Sample (b)(6), initial result was 587 umol/l, and the repeat result was 194 umol/l.Sample (b)(6), initial result was 650 umol/l, and the repeat result was 295 umol/l.
Additional Manufacturer Narrative
The received customer reagent cassette appeared to have a deep red, abnormal color for the r2.Also, the r1 reagent was a slightly brownish-red, clear solution.A retention reagent cassette was checked, and calibration could be performed without error.After the successful calibration, the color of the reagent was checked, and both reagents were colorless.The affected reagent cassette was emptied and tested for microleakage.Microleakage was confirmed between the chambers.The root cause was isolated micro-defects in the cobas c pack large cassettes.

• Brand Name: URIC ACID VER.2
• Common Device Name: URIC ACID TEST SYSTEM
• 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: 23082834
• Report Number: 1823260-2025-03086
• Device Sequence Number: 4748549
• Product Code: KNK
• UDI-Device Identifier: 04015630925124
• UDI-Public: 04015630925124
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K922762
• 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): 12/01/2025

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: 11/30/2025
• Device Model Number: 5171857190
• Device Catalogue Number: 05171857190
• Device Lot Number: 84558901
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 12/01/2025
• 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 Sex: Unknown