BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 295275 · Received September 7, 2000

    Report

    Report Number
    1628664-2000-00055
    Event Type
    Other
    Date Received
    September 7, 2000
    Date of Event
    August 13, 2000
    Report Date
    September 6, 2000
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN AXSYM BETA HUMAN CHORIONIC GONADOTROPIN RESULT OF <O.5 MLU/ML ON 08/13/2000. THE SAMPLE WAS RETESTED ON 08/15/2000 YIELDING A RESULT OF 55 MIU/ML. THE CUSTOMER WAS CONTACTED BY THE PHYSICIAN REGARDING THE RESULTS. THERE IS NO REPORT OF IMPACT TO PT MANAGEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR LOT NUMBER 64583Q100.| AXSYM BHCG REAGENT LIST NUMBER 7A59-22,