BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG

    MDR report key: 24531958 · Received March 6, 2026

    Report

    Report Number
    3008344661-2026-00051
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    February 18, 2026
    Report Date
    April 29, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740167714
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 06C36, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 04P53, AND A PMA NUMBER OF P110029.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT HBSAG RESULTS FOR A 50-YEAR-OLD MALE CHRONIC HEPATITIS B PATIENT. THE FOLLOWING DATA WAS PROVIDED (<0.05 IU/ML IS NONREACTIVE, >/=0.05 IU/ML IS REACTIVE): SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2026, WAS 0.02, REPEAT RESULT, UNDER SAMPLE ID(B)(6), WAS 0.01 IU/ML. THE SAMPLE WAS TESTED USING AN AUTOBIO ASSAY AND THE RESULT WAS POSITIVE. A DIFFERENT SAMPLE WAS TESTED FOR THIS PATIENT, SAMPLE ID(B)(6), AND THE RESULT WAS 0.07, REPEAT RESULT, UNDER SAMPLE ID (B)(6), WAS 0.08 IU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593590 ARCHITECT HBSAG TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 82107FZ01 00380740167714

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male ARC I2000SR INST, 03M74-02, ISR64676