BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMX TOTAL BHCG

    MDR report key: 315048 · Received February 2, 2001

    Report

    Report Number
    2623532-2001-00003
    Event Type
    Malfunction
    Date Received
    February 2, 2001
    Date of Event
    January 4, 2001
    Report Date
    February 1, 2001
    Manufacturer
    ABBOTT HEALTH PRODUCTS, INC.
    Product Code
    JHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S SERUM SAMPLE TESTED ON THE IMX ANALYZER WITH THE IMX B-HCG ASSAY RECEIVED A VALUE OF 150.73 MLU/ML ON THE INITIAL ASSAY RUN AND A VALUE OF 153.63 MLU/ML ON THE REPEAT ASSAY RUN (POSITIVE IF GREATER THAN 25 MLU/ML). THE PATIENT'S SERUM SAMPLE WAS ALSO TESTED WTIH QUALITATIVE METHODS FROM GENZYME AND WAMPOLE WITH A RESULT OF NEGATIVE. A URINE SAMPLE WAS OBTAINED FROM THE PT AND TESTED BY THE BECKMAN FLEXSURE METHOD WITH A RESULT OF NEGATIVE. ANOTHER SERUM SAMPLE WAS DRAWN AND TESTED WITH THE ACS 180 ANALYZER AT ANOTHER LABORATORY WITH A RESULT OF 10 MLU/ML (BODERLINE RESULT BY THIS METHOD). THIS SAME SAMPLE WAS RUN ON THE IMX ANALYZER BACK AT THE ORIGINAL LABORATORY WITH A RESULT OF 167.73 MLU/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4016 IMX TOTAL BHCG MEIA FOR MEASUREMENT OF TOTAL BHCG JHI ABBOTT HEALTH PRODUCTS, INC. NA 70459Q100

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other ABBOTT IMX ANALYZER.