BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-HBC II

    MDR report key: 23169482 · Received September 29, 2025

    Report

    Report Number
    1823260-2025-03962
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    December 21, 2023
    Report Date
    September 29, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LOM
    PMA / PMN Number
    P100032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OCCURRED ON A COBAS E 801 ANALYZER WITH SERIAL NUMBER (B)(6). THE INVESTIGATION DETERMINED THAT THE ELECSYS ANTI-HBC ASSAY PERFORMED WITHIN SPECIFICATIONS. A REVIEW OF CALIBRATION DATA CONFIRMED THAT SIGNALS WERE WITHIN EXPECTED RANGES. HOWEVER, THE INVESTIGATION WAS LIMITED BY THE UNAVAILABILITY OF QUALITY CONTROL DATA AND ADDITIONAL PATIENT SAMPLE TESTING. THE RESULTS WERE OBTAINED USING DIFFERENT KIT LOTS, AND THE MEASURING CELL OF THE ANALYZER WAS REPLACED ON (B)(6) 2023, WHICH MAY HAVE INFLUENCED THE RESULTS. A LIST OF DRUGS THE PATIENT WAS TAKING WAS PROVIDED; THESE DRUGS WERE NOT TESTED REGARDING A POSSIBLE INFLUENCE ON THE ELECSYS AHBC RESULT. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. IT WAS RECOMMENDED TO PERFORM TESTING WITH AN INDEPENDENT METHOD AND TO ASSESS THE RESULTS IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ANTI-HBC G2 ELECSYS E2G 300 V2 ASSAY ON THE COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2023, THE PATIENT SAMPLE WAS TESTED USING KIT LOT 718073 AND GENERATED A REACTIVE RESULT OF 0.636 COI, WITH A RE-RUN RESULT OF 0.618 COI (REACTIVE). ON (B)(6) 2023, THE MEASURING CELL OF THE ANALYZER WAS REPLACED. ON (B)(6) 2024, A SECOND SAMPLE COLLECTED FROM THE PATIENT WAS TESTED USING KIT LOT 741752 AND GENERATED NON-REACTIVE RESULTS OF 1.16 COI, 0.99 COI (AT THE CUT-OFF), AND 1.33 COI (NON-REACTIVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773409 ELECSYS ANTI-HBC II HEPATITIS B TEST (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ROCHE DIAGNOSTICS 718073/741752

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CICLETANINE.| COVERAM.| INEXIUM.| KARDÉGIC.| METFORMINE.| SITAGLIPTINE.| TRINIBUTINE.