BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 22148959 · Received June 5, 2025

    Report

    Report Number
    1823260-2025-01731
    Event Type
    Malfunction
    Date Received
    June 5, 2025
    Date of Event
    May 14, 2025
    Report Date
    June 25, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE URIC ACID REAGENT LOT NUMBER WAS 840301. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER DETERMINED THE WASH MECHANISM WAS OVERFLOWING. THE WASH VOLUMES WERE ADJUSTED. REAGENT AND SAMPLE PIPETTORS WERE FOUND TO BE MIS-ADJUSTED, SO THESE WERE ADJUSTED. PRECISION STUDIES AND ANALYZER CHECKS WERE PERFORMED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH URIC ACID VER.2 ON A COBAS C 503 ANALYTICAL UNIT. THE FIRST SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.803 MG/DL AND IT REPEATED AS 5.01 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762032 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown