BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URIC ACID VER.2

    MDR report key: 23876614 · Received December 23, 2025

    Report

    Report Number
    1823260-2025-05313
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    November 27, 2025
    Report Date
    February 6, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KNK
    PMA / PMN Number
    K922762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS INTEGRA 400 PLUS SERIAL NUMBER IS (B)(6). THE QC AND CALIBRATION WERE PASSING AT THE TIME OF THE EVENT. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE WATER QUALITY IS 3 S/CM; BASED ON THE TECHNICAL SPECIFICATIONS, THE LIMITS FOR WATER CONDUCTIVITY ARE < 1.5 S/CM. THE CUSTOMER CHANGED THE WATER SOURCE, WHICH HAD HIGH CONDUCTIVITY, AND THEY ARE REVIEWING THEIR PREANALYTICAL STEPS. THE PHOTOMETER LAMP WAS LAST REPLACED ON (B)(6) 2025 AND IS TO BE EXCHANGED AFTER 800 HOURS IN OPERATING OR STANDBY MODE. THE INVESTIGATION DETERMINED THAT A GENERAL REAGENT OR ANALYZER PROBLEM WAS NOT PRESENT BECAUSE THE QC PRIOR TO THE EVENT WAS WITHIN RANGES. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE AS THERE WAS LIMITED INFORMATION AVAILABLE. THE MOST LIKELY ROOT CAUSE IS A COMBINATION OF DIFFERENT CUSTOMER HANDLING ISSUES (PRE-ANALYTICS, MAINTENANCE ACTIONS, WATER QUALITY).

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE URIC ACID VER.2 RESULT FROM THE COBAS INTEGRA 400 PLUS FOR ONE PATIENT. THE INITIAL RESULT WAS 12.8 MG/DL, ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS 7.9 MGDL, ACCOMPANIED BY A DATA FLAG. THE CUSTOMER ALSO PROVIDED QUESTIONABLE CREATININE PLUS VER.2 RESULTS FOR ONE PATIENT AND CALCIUM GEN.2 RESULTS FOR ONE PATIENT. THIS MEDWATCH WILL COVER THE URIC ACID VER.2 ASSAY. SEE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE CREATININE PLUS VER.2 ASSAY. SEE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE CALCIUM GEN.2 ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383377 URIC ACID VER.2 URIC ACID TEST SYSTEM KNK ROCHE DIAGNOSTICS 87550401

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown