BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 579972 · Received June 30, 2004

    Report

    Report Number
    1628664-2004-00022
    Event Type
    Other
    Date Received
    June 30, 2004
    Date of Event
    May 19, 2004
    Report Date
    June 25, 2004
    Manufacturer
    ABBOTT MGG, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT AN AXSYM BHCG RESULT OF 30 MIU/ML WAS REPORTED ON A PT AND QUESTIONED BY THE PHYSICIAN. THE ORIGINAL SAMPLE ALIQUOT WAS RETESTED YIELDING A RESULT OF 1135 MIU/ML. THE ORIGINAL SAMPLE TUBE WAS TESTED YIELDING A RESULT OF 1151 MIU/ML. THE CUSTOMER IS UNSURE WHETHER PT MANAGEMENT WAS IMPACTED BASED ON THE INITIAL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MGG, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR AXSYM TOTAL BHCG REAGENT LIST NO. 7A59-22 LOT NO.| 13643Q100.