BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 25142687 · Received May 11, 2026

    Report

    Report Number
    1823260-2026-01850
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 11, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 944640. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND A DRIPPING NOZZLE. HE ADJUSTED THE DETERGENT VOLUME AND REPLACED THE SPRING ON THE NOZZLE. HE PERFORMED VALIDATION CHECKS WITH ACCEPTABLE RESULTS. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 28.8 MOL/L. THE REPEATED RESULTS WERE 90.0 MOL/L AND 90.3 MOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462237 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1