BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23956755 · Received January 5, 2026

    Report

    Report Number
    1219913-2026-00002
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    June 20, 2025
    Report Date
    January 27, 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

    A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF AN ERRONEOUS ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. SIEMENS IS INVESTIGATING. NOTE: FOR SECTION G3 / G4, PMA/510(K) NUMBER = P100039-S005_P100039-S016.

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF A FALSE POSITIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. UPDATE, 27-JAN-2025: SIEMENS HAS CONCLUDED THE INVESTIGATION. THE CUSTOMER REPORTED MULTIPLE OBSERVATIONS OF DISCORDANCE INVOLVING MULTIPLE AHBS2 PRODUCT LOTS. [OTHER EVENTS REPORTED SEPARATELY TO FDA.] SIEMENS INVESTIGATION INCLUDED A COMPREHENSIVE REVIEW OF REAGENT AND INSTRUMENT PERFORMANCE. REAGENT-RELATED ISSUES WERE RULED OUT ON THE BASIS OF DEMONSTRATED QUALITY CONTROL (QC) AND A REVIEW OF CURRENT ASSAY PERFORMANCE. NO ISSUES WERE IDENTIFIED WITH QC OR OTHER PATIENT SAMPLES IN THE TIMEFRAME OF THE REPORTED DISCORDANCE. TESTING FOR POTENTIAL INTERFERENTS, INCLUDING HETEROPHILIC ANTIBODIES (HBT OR NABT), WAS NOT PERFORMED BY THE CUSTOMER. THE ORIGINAL PATIENT SAMPLES WERE NOT AVAILABLE FOR TESTING BY SIEMENS, AND THE CUSTOMER DECLINED TO PROVIDE ADDITIONAL CLINICAL OR ANALYTICAL INFORMATION. AS A RESULT, SIEMENS WAS UNABLE TO PERFORM ADDITIONAL INVESTIGATIVE TESTING. BASED ON THE AVAILABLE INFORMATION, A SPECIFIC CAUSE FOR THE OBSERVED DISCORDANCE COULD NOT BE DETERMINED. THE CUSTOMER IS OPERATIONAL, AND NO EVIDENCE OF A SYSTEMIC REAGENT- OR INSTRUMENT-RELATED ISSUE WAS IDENTIFIED. NOTE: IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS OBSERVATION OF AN ERRONEOUS ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. AN INITIAL REACTIVE RESULT OF (B)(6) 2025 WAS IDENTIFIED AS FALSELY ELEVATED (FALSE POSITIVE). A SECOND SAMPLE, TESTED (B)(6) 2025, PRODUCED A NONREACTIVE RESULT WHICH WAS REPRODUCED IN REPEAT TESTING OF BOTH SAMPLES. THE INITIAL RESULT WAS CORRECTED. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17162 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 42959177 00630414597836

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male