BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 22965975 · Received September 4, 2025

    Report

    Report Number
    1823260-2025-02742
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 17, 2025
    Report Date
    September 23, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CALIBRATION AND QC WERE ACCEPTABLE FOR BOTH ASSAYS. THERE IS NO INDICATION OF A REAGENT PERFORMANCE ISSUE. THERE WERE MULTIPLE ABNORMAL ASPIRATIONS AND SAMPLE SHORT ALARMS NOTED ON THE DATE OF THE EVENT, NEAR THE TIME THE SAMPLE WAS PROCESSED. THE FIELD SERVICE ENGINEER (FSE) FOUND THE RINSE BATH CELLS WERE OVERFLOWING DUE TO A BLOCKED VACUUM VALVE. THE FSE CLEANED THE VALVE AND PERFORMED A PRECISION CHECK WITH NO ISSUES. THE CELLS WERE BEING EVACUATED CORRECTLY. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO A MAINTENANCE ISSUE.

    Additional Manufacturer Narrative · 0

    THE CA2 REAGENT LOT NUMBER WAS 880047 WITH AN EXPIRATION DATE OF 31-AUG-2026. THE GLUC3 REAGENT LOT NUMBER WAS 860069 WITH AN EXPIRATION DATE OF 31-MAY-2026.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF DISCREPANT LOW RESULTS FOR 1 PATIENT SAMPLE TESTED FOR CALCIUM GEN.2 (CA2) AND GLUCOSE HK GEN.3 (GLUC3) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL CA2 RESULT WAS 5.1 MG/DL. THE REPEAT RESULT WAS 7.9 MG/DL. THE INITIAL GLUC3 RESULT WAS 49 MG/DL. THE REPEAT RESULT WAS 104 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2412557 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown