BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URIC ACID VER.2

    MDR report key: 23082834 · Received September 18, 2025

    Report

    Report Number
    1823260-2025-03086
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    August 26, 2025
    Report Date
    December 1, 2025
    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 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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647836 URIC ACID VER.2 URIC ACID TEST SYSTEM KNK ROCHE DIAGNOSTICS 5171857190 84558901 04015630925124

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown