BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 23544162 · Received November 13, 2025

    Report

    Report Number
    1823260-2025-04620
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    October 23, 2025
    Report Date
    November 13, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER WAS 889120. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) REPLACED AND CALIBRATED THE SAMPLE NEEDLE AT ALL POINTS. THE FSE VERIFIED THE DISPENSING AND DRYING OF THE WASHING STATION. FOLLOWING THE FSE INTERVENTION, THE INSTRUMENT WAS CONFIRMED TO BE WORKING WITHIN SPECIFICATIONS AND NO FURTHER ISSUE WAS OBSERVED. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUA ESTIONABLE GLUCOSE HK GEN.3 RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 6.20 MG/DL. THE REPEAT RESULT WAS 97.9 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2249874 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown