BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URIC ACID VER.2

    MDR report key: 25073316 · Received May 4, 2026

    Report

    Report Number
    1823260-2026-01735
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 4, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KNK
    UDI-DI
    04015630925124
    PMA / PMN Number
    K922762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81205 URIC ACID VER.2 URIC ACID TEST SYSTEM KNK ROCHE DIAGNOSTICS 5171857190 91201001 04015630925124

    Patients

    Seq Age Sex Outcome Treatment
    1