BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 21892160 · Received April 23, 2025

    Report

    Report Number
    1823260-2025-01245
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    April 3, 2025
    Report Date
    July 22, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETE NAME FOR MEDWATCH FIELD E1 INITIAL REPORTER ESTABLISHMENT NAME: (B)(6). THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    SECTION D, DEVICE IDENTIFICATION WAS UPDATED. RELEVANT FIELDS OF SECTIONS D AND G WERE UPDATED. THE CREATININE PLUS VER.2 REAGENT LOT NUMBER IS 853138, AND THE EXPIRATION DATE IS 31-OCT-2025. A FIELD SERVICE ENGINEER (FSE) DISCOVERED BUILD-UP ON A SAMPLE PROBE. THE FSE VERIFIED ADJUSTMENTS AND THE GEAR PUMP PRESSURE, AND DECONTAMINATED THE SAMPLE PROBE. QC AND CALIBRATION WERE PASSING BEFORE THE EVENT, SO A GENERAL REAGENT ISSUE IS UNLIKELY. THE INVESTIGATION DETERMINED THAT THERE WERE NO INDICATORS OF PRODUCT-RELATED ISSUES IDENTIFIED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT, RESULTS WERE PROVIDED FOR 1 PATIENT. THE INITIAL RESULT WAS 208 UMOL/L, AND THE REPEAT RESULT ON ANOTHER ANALYZER WAS 62.8 UMOL/L. THE INITIAL RESULT WAS QUESTIONED BY THE PATIENT AND WAS THEN REPEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258233 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 853138

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown