BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXSYM TOTAL BHCG

    MDR report key: 516302 · Received January 20, 2004

    Report

    Report Number
    2623532-2004-00001
    Event Type
    Other
    Date Received
    January 20, 2004
    Date of Event
    December 15, 2003
    Report Date
    January 19, 2004
    Manufacturer
    ABBOTT HEALTH PRODUCTS, INC.
    Product Code
    JHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT AN AXSYM BHCG RESULT OF 2.18 IU/L WAS REPORTED ON A PT WITH STOMACH PAIN AND BLEEDING IN 2003. THE SAME PT WAS REDRAWN THE NEXT DAY AND THE AXSYM BHCG RESULT WAS 120 IU/L. THE SAMPLE DRAWN THE PREVIOUS DAY WAS RETESTED YIELDING A RESULT OF 100 IU/L TWICE. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM TOTAL BHCG IMMUNOASSAY FOR MEASUREMENT OF TOTAL BHCG JHI ABBOTT HEALTH PRODUCTS, INC. NA 09439Q101

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR AXSYM ANALYZER.