BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2)

    MDR report key: 23560686 · Received November 14, 2025

    Report

    Report Number
    1219913-2025-00208
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    October 25, 2025
    Report Date
    May 19, 2026
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOM
    UDI-DI
    00630414597836
    PMA / PMN Number
    SEE H10
    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 CUSTOMER REPORTS DISCORDANT REACTIVE (POSITIVE) ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) LOT 176 RESULTS ON A PATIENT SAMPLE RELATIVE TO ALTERNATE METHOD TESTING. THE INITIAL DISCORDANT RESULT WAS REPORTED TO THE PATIENT. THE PATIENT WAS KNOWN TO BE NEGATIVE IN 2024; THEREFORE, THE SAMPLE WAS RETESTED BY THE CUSTOMER AND RESULT WAS POSITIVE. SAMPLE WAS ALSO SENT TO 2 OTHER LABS, AND THE RESULTS WERE NEGATIVE AND BELIEVED TO BE CORRECT. THE NEGATIVE RESULT WAS REPORTED. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT. QUALITY CONTROL (QC) RESULTS WERE WITHIN ACCEPTABLE RANGES AT THE TIME OF TESTING. FOR TROUBLESHOOTING, AN HISTORICAL SAMPLE THAT RESULTED NEGATIVE ON ATELLICA IM ON (B)(6) 2025 WAS RETESTED AT THE CUSTOMER SITE WITH LOT 176 AND RESULTED POSITIVE. SAMPLE WAS ALSO TESTED AT ANOTHER LAB WITH LOT 177 AND WAS NEGATIVE. SIEMENS IS INVESTIGATING. NOTE: PER SECTION G3 / G4, PMA/510(K)NUMBER = P100039-S005_P100039-S016.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS DISCORDANT REACTIVE (POSITIVE) ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) LOT 176 RESULTS ON A PATIENT SAMPLE RELATIVE TO ALTERNATE METHOD TESTING. THE INITIAL DISCORDANT RESULT WAS REPORTED TO THE PATIENT. THE PATIENT WAS KNOWN TO BE NEGATIVE IN 2024, THEREFORE THE SAMPLE WAS RETESTED BY THE CUSTOMER AND RESULT WAS POSITIVE. SAMPLE WAS ALSO SENT TO 2 OTHER LABS, AND THE RESULTS WERE NEGATIVE AND BELIEVED TO BE CORRECT. THE NEGATIVE RESULT WAS REPORTED. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105289 ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 05988176 00630414597836

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female