BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG

    MDR report key: 23922383 · Received December 30, 2025

    Report

    Report Number
    3008344661-2025-00191
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 17, 2025
    Report Date
    February 4, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740167707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATA AND INFORMATION PROVIDED WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT HBSAG ASSAY DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE ARCHITECT HBSAG ASSAY AND COMPLAINT ISSUE. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. REVIEW OF THE PUBLICATIONS, H. W. REESINK ET AL. ¿OCCULT HEPATITIS B INFECTION IN BLOOD DONORS¿, VOX SANGUINIS (2008) 94, 153-166 AND MICHAEL TORBENSON AND DAVID L THOMAS ¿OCCULT HEPATITIS B¿, LANCET INFECT DIS 2002; 2: 479-86, THIS COULD POTENTIALLY BE A CASE OF OCCULT HBV INFECTION WHICH IS A KNOWN PHENOMENON AND IS DIAGNOSED WHEN A HBV DNA TEST IS POSITIVE BUT HBSAG IS UNDETECTED. OCCULT INFECTION MAY REPRESENT ACUTE INFECTION IN THE WINDOW PERIOD, HBV TAIL END OF CHRONIC HBV INFECTION, PERSISTENCE OF REPLICATION AT LOW LEVEL AFTER RECOVERY IN THE PRESENCE OF ANTI-HBS OR OCCURRENCE OF AN ESCAPE MUTANT IN VACCINATED OR UNVACCINATED INDIVIDUALS NOT DETECTED BY CURRENT HBSAG ASSAYS. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT HBSAG REAGENT WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 6C36 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4P53, AND 510K/PMA/BLA OF P110029. SECTION A PATIENT INFORMATION: NO ADDITIONAL INFORMATION PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NEGATIVE ARCHITECT HBSAG RESULT. A PATIENT WITH CHRONIC HEPATITIS B UNDERGOING ANTIVIRAL THERAPY HAD A NEGATIVE HBSAG RESULT BUT A WEAKLY POSITIVE HBV-DNA RESULT. THE MEDICAL HISTORY IS HBSAG OF 0.2 IU/ML, REACTIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NEGATIVE ARCHITECT HBSAG RESULT. A PATIENT WITH CHRONIC HEPATITIS B UNDERGOING ANTIVIRAL THERAPY HAD A NEGATIVE HBSAG RESULT BUT A WEAKLY POSITIVE HBV-DNA RESULT. THE MEDICAL HISTORY IS HBSAG OF 0.2 IU/ML, REACTIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1835756 ARCHITECT HBSAG TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 00380740167707

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male ARC I2000SR INST, 03M74-02, (B)(6)