BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG REAGENT KIT

    MDR report key: 16500113 · Received March 7, 2023

    Report

    Report Number
    3005094123-2023-00065
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    February 10, 2023
    Report Date
    March 14, 2023
    Manufacturer
    A.I.D.D LONGFORD
    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 B-HCG, LIST 07K78-77, A.I.D.D LONGFORD, LONGFORD, IRELAND TO THE ARCHITECT I2000SR PROCESSING MODULE, LIST 03M74-02, ABBOTT LABORATORIES, IRVING, TEXAS, USA. MDR NUMBER 3016438761-2023-00140-00 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 B-HCG RESULT ON A PATIENT WHO WAS DIAGNOSED WITH PARTIAL HYDATIDIFORM MOLE AND HAD UNDERGONE SURGICAL RESECTION. THE RESULT WAS QUESTIONED BY THE PHYSICIAN AS IT WAS NOT CONSISTENT WITH THE PATIENT¿S CLINICAL DIAGNOSIS. A NEW SAMPLE WAS TESTED, AND THE RESULT WAS NEGATIVE. THE ORIGINAL SAMPLE WAS ALSO RETESTED, AND THE RESULT WAS NEGATIVE. THE FOLLOWING DATA WAS PROVIDED: ORIGINAL SAMPLE: INITIAL RESULT = 153.72 MIU/ML (POSITIVE); REPEAT RESULT = < 1.2 MIU/ML (NEGATIVE). NEW SAMPLE: RESULT = < 1.2 MIU/ML (NEGATIVE). COLLOIDAL GOLD TEST = NEGATIVE. ADDITIONAL INFORMATION RECEIVED ON 03MAR2023. IT WAS NOTED THAT THE FILTER TO THE CUSTOMER¿S WATER SYSTEM HAD NOT BEEN REPLACED FOR A LONG TIME. IT IS SUSPECTED THAT THE CUSTOMER'S WATER MAY HAVE CONTRIBUTED TO THE DISCREPANT RESULT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776565 ARCHITECT TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA A.I.D.D LONGFORD 42330UD02

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC I2000SR INST, 03M74-02, ISR64377| ARC I2000SR INST, 03M74-02, ISR64377