BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXSYM TOTAL BHCG

    MDR report key: 271287 · Received March 27, 2000

    Report

    Report Number
    1628664-2000-00015
    Event Type
    Other
    Date Received
    March 27, 2000
    Date of Event
    October 22, 1999
    Report Date
    March 23, 2000
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    JHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 10/22/1999 PT HAD AXSYM BHCG RESULT OF 113 MLU/ML. PHYSICIAN TREATED WITH METHOTREXATE. BHCG VALUES DIMINISHED AS FOLLOWS: 11/29/1999, 38 MLU/ML; 12/04/1999, 36 MLU/ML; 12/13/1999, 34 MLU/ML; 12/27/1999, 32 MLU/ML; 01/04/2000, 28 MLU/ML; 01/10/2000, 27 MLU/ML AND 01/26/2000, 24 MLU/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM TOTAL BHCG MEIA FOR MEASUREMENT OF TOTAL BHCG JHI ABBOTT LABORATORIES, INC. NA 52158Q101 AND 57188Q100

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR ABBOTT AXSYM INSTRUMENT LIST #7A83-01.