BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HBS REAGENT KIT

    MDR report key: 15788415 · Received November 14, 2022

    Report

    Report Number
    3008344661-2022-00156
    Event Type
    Malfunction
    Date Received
    November 14, 2022
    Date of Event
    November 5, 2022
    Report Date
    January 23, 2023
    Manufacturer
    ABBOTT IRELAND
    Product Code
    LOM
    PMA / PMN Number
    P050051
    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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7C18 HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1L82.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT ANTI-HBS, 07C18-78, ABBOTT IRELAND TO ARCHITECT I2000SR PROCESSING MODULE, 03M74-02, ABBOTT LABORATORIES IRVING. MDR NUMBER 3016438761-2023-00034-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER. H3 OTHER TEXT : AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT ANTI-HBS, 07C18-78, ABBOTT IRELAND TO ARCHITECT I2000SR PROCESSING MODULE, 03M74-02, ABBOTT LABORATORIES IRVING. MDR NUMBER 3016438761-2023-00034-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT ANTI-HBS RESULT FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 74.11 MIU/ML (PROTECTIVE), REPEAT = 1.76 MIU/ML (NOT PROTECTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830200 ARCHITECT ANTI-HBS REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND 34344FN01

    Patients

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