BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HBS

    MDR report key: 22922908 · Received August 29, 2025

    Report

    Report Number
    3008344661-2025-00122
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    August 19, 2025
    Report Date
    October 22, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740165352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, IN HOUSE TESTING AND LABELING REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER CONFIRMS THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT ANTI-HBS ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY REGARDING COMMONALITIES FOR COMPLAINT LOT AND ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 69530FZ01. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCE, POTENTIAL NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER AND COMPLAINT ISSUE. IN HOUSE SPECIFICITY TESTING WAS PERFORMED USING A RETAINED KIT OF THE COMPLAINT LOT. ALL ACCEPTANCE CRITERIA WAS MET AND THE PRODUCT IS PERFORMING AS EXPECTED. A REVIEW OF THE LABELLING ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT ANTI-HBS REAGENT LOT 69530FZ01 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ARCHITECT ANTI-HBS, LIST NUMBER 07C18-78 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, ARCHITECT AUSAB, LIST NUMBER 01L82, WITH 510K/PMA/BLA NUMBER P050051. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT ANTI-HBS RESULT GENERATED BY THE ARCHITECT I2000SR PROCESSING MODULE FOR A PATIENT SAMPLE. UPON REPEAT TESTING, LOWER RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: INITIAL ARCHITECT ANTI-HBS RESULT: 12.96 MIU/ML REPEAT RESULTS: 0.86 MIU/ML AND 0.91 MIU/ML PER THE ARCHITECT ANTI-HBS PACKAGE INSERT, INTERPRETATION OF RESULTS SECTION, AN ANTI-HBS CONCENTRATION = 10 MIU/ML IS REGARDED AS BEING PROTECTIVE AGAINST HEPATITIS B VIRAL INFECTION. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT ANTI-HBS RESULT GENERATED BY THE ARCHITECT I2000SR PROCESSING MODULE FOR A PATIENT SAMPLE. UPON REPEAT TESTING, LOWER RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: INITIAL ARCHITECT ANTI-HBS RESULT: 12.96 MIU/ML. REPEAT RESULTS: 0.86 MIU/ML AND 0.91 MIU/ML. PER THE ARCHITECT ANTI-HBS PACKAGE INSERT, INTERPRETATION OF RESULTS SECTION, AN ANTI-HBS CONCENTRATION = 10 MIU/ML IS REGARDED AS BEING PROTECTIVE AGAINST HEPATITIS B VIRAL INFECTION. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2864545 ARCHITECT ANTI-HBS TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 69530FZ01 00380740165352

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2000SR INST, 03M74-02, (B)(6)