BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 579809 · Received August 23, 2004

    Report

    Report Number
    1628664-2004-00028
    Event Type
    Other
    Date Received
    August 23, 2004
    Date of Event
    July 27, 2004
    Report Date
    August 20, 2004
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE FOLLOWING AXSYM BHCG RESULTS WERE GENERATED ON A PT: BHCG =15,000 IU/L. 2 DAYS LATER BHCG=65,000 IU/L. THE SAMPLE FROM 2 DAYS AGO WAS RETESTED YIELDING RESULTS OF 39,000 AND 42,240 IU/L. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN AXSYM BHCG TOTALE LIST #7A59-21 LOT#UNK.