BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 280544 · Received May 31, 2000

    Report

    Report Number
    1628664-2000-00036
    Event Type
    Other
    Date Received
    May 31, 2000
    Date of Event
    April 27, 2000
    Report Date
    May 25, 2000
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON MARCH 27, THE ACCOUNT REPORTED OUT AN AXSYM BHCG VALUE OF 364 MIU/ML. THE PT WENT FOR AN ABORTION. THE PT HAD A PHYSICAL EXAM WHICH SHOWED NO SIGNS OF PREGNANCY. AN ADDITIONAL PREGNANCY TEST WAS PERFORMED WITH NEGATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM MEIA FOR THE DETERMINATION OF HCG JJE ABBOTT LABORATORIES, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR AXSYM BHCG ASSAY, LIST NUMBER 7A59-22.