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

Model Number	5171857190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 c702 module serial number was (b)(6).The qc was acceptable.Upon removing the reagent and inspecting its condition, the customer found that it had turned dark red in color.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 5 patients' samples tested with uric acid ver.2 assay on a cobas 8000 c702 module.Sample 1: initial result: 702.2 mmol/l.Repeat result: 244.4 mmol/l.Sample 2: initial result: 683.9 mmol/l.Repeat result: 242.9 mmol/l.Sample 3: initial result: 692.6 mmol/l.Repeat result: 298.8 mmol/l.Sample 4: initial result: 681.7 mmol/l.Repeat result: 229.4 mmol/l.Sample 5: initial result: 675.9 mmol/l.Repeat result: 439.4 mmol/l.The customer questioned the initial results as they did not match the patients' clinical diagnosis, and repeated the samples after replacing the reagent.No questionable results were reported outside the laboratory.The results with the lower values were deemed to be correct.

• 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: 25073316
• Report Number: 1823260-2026-01735
• Device Sequence Number: 10418244
• 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
• Report Date (Section B): 05/04/2026

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 Model Number: 5171857190
• Device Catalogue Number: 05171857190
• Device Lot Number: 91201001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/04/2026
• 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: Unknown