BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 22990896 · Received September 8, 2025

    Report

    Report Number
    1823260-2025-02775
    Event Type
    Malfunction
    Date Received
    September 8, 2025
    Date of Event
    August 21, 2025
    Report Date
    September 8, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IRON REAGENT LOT NUMBER WAS 861350. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER REPLACED AND ADJUSTED THE SAMPLE PROBE AND PERFORMED INSTRUMENT ADJUSTMENTS. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE LOW IRON RESULTS FOR THREE PATIENT SAMPLES FROM THE COBAS C 503 ANALYTICAL UNIT. ONE EXAMPLE WAS PROVIDED. THE INITIAL RESULT WAS 8.24 G/DL. THE REPEAT RESULTS WERE 6.81 G/DL AND 8.11 G/DL. THE REPEAT RESULT FROM A COBAS 6000 C501 ANALYZER WAS 16.43 G/DL. THIS RESULT WAS BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2495943 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown