BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG

    MDR report key: 25287982 · Received May 26, 2026

    Report

    Report Number
    3008344661-2026-00077
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    May 15, 2026
    Report Date
    May 26, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740167721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ARCHITECT HBSAG, LIST NUMBER 06C36 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, ARCHITECT HBSAG QUALITATIVE, LIST NUMBER 04P53, WITH 510K/PMA/BLA NUMBER P110029.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT HBSAG ON A 40-YEAR-OLD MALE PATIENT WHO WAS DIAGNOSED WITH HEPATITIS B. THE RESULTS PROVIDED WERE: (B)(6) 2026, SID (B)(6); RESULT WAS = 0.01 IU/ML (NONREACTIVE), REPEAT RESULT FROM SIEMENS= NONREACTIVE (NO DATA PROVIDED), HBVDNA RESULT = 2.29 (POSITIVE). HISTORICAL RESULTS FROM (B)(6) 2026; 2.55 IU/ML (REACTIVE) & SIEMENS RESULTS WERE ALSO REACTIVE. (NO DATA PROVIDED). HBVDNA = 2.12 IU/ML (POSITIVE ON (B)(6) 2026). HBSAG = (REFERENCE RANGE: < 0.05 IU/ML IS NONREACTIVE, = 0.05 IU/ML IS REACTIVE). HBV-DNA= (REFERENCE RANGE: <20 IU/ML). OTHER RESULTS = ON (B)(6) 2026; ALT, AST, TBIL, AND DBIL RESULTS WERE ALL HIGHER THAN THE REFERENCE RANGE AND RESULTS DECLINED AFTER RECEIVING TREATMENT TO PROTECT THE LIVER, LOWER ENZYMES, AND REDUCE JAUNDICE. CUSTOMER ONLY QUESTION HBSAG RESULTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179175 ARCHITECT HBSAG TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 82117FZ01 00380740167721

    Patients

    Seq Age Sex Outcome Treatment
    1