BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOT AXSYM SYSTEM

    MDR report key: 549514 · Received April 5, 2004

    Report

    Report Number
    1628664-2004-00012
    Event Type
    Other
    Date Received
    April 5, 2004
    Date of Event
    February 28, 2004
    Report Date
    April 1, 2004
    Manufacturer
    ABBOTT MANUFACTURING INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE AXSYM BHCG RESULT OF 3,600 IU/L WAS REPORTED ON A PREGNANT PT AND WAS QUESTIONED BY THE PHYSICIAN. A SECOND SAMPLE WAS DRAWN AND THE RESULT WAS 26,000 IU/L. THE FIRST PT SAMPLE WAS RETESTED YEILDING A RESULT OF 22,000 IU/L. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN AXSYM TOTAL BHCG REAGENT LIST NO. 7A59-21, LOT NO.| 11293Q102.