BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HBS REAGENT KIT

    MDR report key: 21871302 · Received April 21, 2025

    Report

    Report Number
    3008344661-2025-00043
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    March 27, 2025
    Report Date
    May 27, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740159931
    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 FOR A FALSELY ELEVATED RESULT INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF THE COMPLAINT TEXT, TRENDING DATA, IN-HOUSE TESTING, LABELLING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. CLINICAL SPECIFICITY OF THE ARCHITECT ANTI-HBS ASSAY WAS EVALUATED WITH A RETAINED KIT OF LOT 65679FZ01 AND DEMONSTRATED ACCEPTABLE SPECIFICITY SPECIFICATIONS, CONFIRMING THAT THIS LOT IS MEETING THE ARCHITECT PRODUCT REQUIREMENT. TRENDING REVIEW DETERMINED NO TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW ON LOT 65679FZ01 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. LABELLING AND LITERATURE WERE REVIEWED WHICH ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT ANTI-HBS ASSAY, LOT NUMBER 65679FZ01WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7C18 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1L82, WITH 510K/PMA/BLA NUMBER P050051.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT ANTI-HBS RESULTS ON A 50-YR OLD MALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) = 390.63 / 453.28 MIU/ML, ANOTHER PLATFORM IS NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT ANTI-HBS RESULTS ON A 50-YR OLD MALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) = 390.63 / 453.28 MIU/ML, ANOTHER PLATFORM IS NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570387 ARCHITECT ANTI-HBS REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 65679FZ01 00380740159931

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male ARC I2000SR INST, 03M74-02, (B)(6) | ARC I2000SR INST, 03M74-02, (B)(6)