BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HBSAG II

    MDR report key: 23070625 · Received September 17, 2025

    Report

    Report Number
    1823260-2025-02966
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    February 25, 2025
    Report Date
    September 17, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LOM
    PMA / PMN Number
    P160019
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OCCURRED ON A COBAS 6000 E601 ANALYZER (SERIAL NUMBER: (B)(6). THE INVESTIGATION DETERMINED THAT THE ELECSYS HBSAG II ASSAY PERFORMED WITHIN SPECIFICATIONS. CALIBRATION AND QUALITY CONTROL DATA FOR LOT 812808 WERE REVIEWED AND CONFIRMED TO BE WITHIN EXPECTED RANGES. THE INITIALLY REACTIVE RESULT IS DESCRIBED IN THE ASSAY'S INSTRUCTIONS FOR USE (IFU) AND REQUIRES DUPLICATE RETESTING. BOTH DUPLICATE RETESTS OF THE SAMPLE YIELDED NON-REACTIVE RESULTS, CONSISTENT WITH THE IFU GUIDANCE. NO ISSUES WERE IDENTIFIED WITH THE ANALYZER, AND THE SPECIAL WASH LIST WAS CONFIRMED TO BE UP TO DATE. THE ROOT CAUSE WAS ATTRIBUTED TO THE NATURE OF INITIALLY REACTIVE RESULTS, WHICH ARE DESCRIBED IN THE IFU AS REQUIRING FURTHER INVESTIGATION. THE DEVICE REMAINS IN OPERATION AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WITH THE HBSAG G2 ELECSYS COBAS E 100 V2 ASSAY ON THE COBAS 6000 E601 MODULE. THE INITIAL TEST RESULT FOR THE SAMPLE WAS REACTIVE WITH A VALUE OF 135.4 COI. THE SAMPLE WAS SPLIT INTO TWO ALIQUOTS FOR DUPLICATE RETESTING. THE FROZEN ALIQUOT YIELDED A RESULT OF 0.450 COI (NON-REACTIVE), AND THE COOLED ALIQUOT YIELDED A RESULT OF 0.417 COI (NON-REACTIVE). TESTING ON A COMPETITOR SYSTEM, WHICH WAS NOT SPECIFIED, ALSO YIELDED A NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636176 ELECSYS HBSAG II HEPATITIS B TEST LOM ROCHE DIAGNOSTICS 812808

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown