BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG REAGENT KIT

    MDR report key: 16728828 · Received April 12, 2023

    Report

    Report Number
    3005094123-2023-00097
    Event Type
    Malfunction
    Date Received
    April 12, 2023
    Date of Event
    March 23, 2023
    Report Date
    April 24, 2023
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT TOTAL -HCG, LIST 07K78-77, ABBOTT IRELAND DIAGNOSTICS DIVISION, LONGFORD, IRELAND TO THE ARCHITECT I2000SR PROCESSING MODULE, LIST 03M74-02, ABBOTT LABORATORIES, IRVING, TEXAS, USA. MDR NUMBER 3016438761-2023-00222-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Additional Manufacturer Narrative · 0

    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 FALSE POSITIVE ARCHITECT TOTAL. HCG RESULT FOR A PATIENT WHEN COMPARED TO ANOTHER METHOD WHICH GENERATED A NEGATIVE RESULT. THE SAMPLE WAS REPEATED AND THE RESULT WAS NEGATIVE. THE FOLLOWING DATA WAS PROVIDED. INITIAL RESULT = 1003.2 MIU/ML (POSITIVE); REPEAT RESULT = <1.2 MIU/ML NEGATIVE. COLLOIDAL GOLD METHOD = NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305215 ARCHITECT TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 42330UD02

    Patients

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