BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG REAGENT KIT

    MDR report key: 18637707 · Received February 4, 2024

    Report

    Report Number
    3005094123-2024-00045
    Event Type
    Malfunction
    Date Received
    February 4, 2024
    Date of Event
    December 25, 2023
    Report Date
    March 7, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    PMA / PMN Number
    K983424
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A1 - PATIENT IDENTIFIER: SIDS = (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT TOTAL B-HCG REAGENT, LIST 07K78-35, ABBOTT IRELAND DIAGNOSTICS DIVISION, LONGFORD, IRELAND TO THE ARCHITECT I2000SR PROCESSING MODULE, LIST 03M74-02, ABBOTT LABORATORIES, IRVING, TEXAS, USA. MDR NUMBER 3016438761-2024-00142 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ARCHITECT TOTAL ¿-HCG RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR TWO PATIENTS. THE SAMPLES WERE NEGATIVE UPON REPEAT. THE CUSTOMER ALSO NOTED THAT THE LEVEL 1 CONTROL SOMETIMES RUN HIGH BUT CAME IN RANGE WHEN REPEATED. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023 SID (B)(6) INITIAL RESULT = 5088.75 MIU/ML (POSITIVE). (B)(6) 2023 REPEAT RESULTS = <1.20MIU/ML, <1.20MIU/ML, <1.20MIU/ML (ALL NEGATIVE). (B)(6) 2024 SID (B)(6) INITIAL RESULT = 124.20 MIU/ML (POSITIVE). (B)(6) 2024 REPEAT RESULT = <1.20MIU/ML (NEGATIVE). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373532 ARCHITECT TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 55315UD00

    Patients

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