BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 3415455 · Received October 17, 2013

    Report

    Report Number
    3005094123-2013-00050
    Event Type
    Malfunction
    Date Received
    October 17, 2013
    Date of Event
    October 1, 2013
    Report Date
    October 2, 2013
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    DHA
    PMA / PMN Number
    K983424
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I2000SR ANALYZER GENERATED A FALSE POSITIVE BHCG RESULT FOR ONE PATIENT SAMPLE. THE ANALYZER GENERATED BHCG RESULTS OF <1.2, 5.09, AND 334.64 IU/L FOR SAMPLE 032921. THE FALSE POSITIVE BHCG RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533930 ARCHITECT TOTAL B-HCG DHA A.I.D.D LONGFORD 26903UI00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER| LN 03M74-02, SN (B)(4)