BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 284763 · Received June 30, 2000

    Report

    Report Number
    1628664-2000-00044
    Event Type
    Other
    Date Received
    June 30, 2000
    Date of Event
    May 18, 2000
    Report Date
    June 29, 2000
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED OUT AXSYM BETA-HUMAN CHORIONIC GONADOTROPHIN. RESULT OF 7864 MIU/ML. RESULT WAS QUESTIONED BY PHYSICIAN. PT WAS TOLD BY PHYSICIAN THAT PT MAY BE MISCARRYING. SAMPLE WAS RETESTED, YIELDING A RESULT OF 39,535 MIU/ML. PT WAS NOT TREATED.

    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 NO INFO LIST NUMBER 7A59-22.| AXSYM BETA-HUMAN CHORIONIC GONADOTROPHIN ASSAY,