BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 221610 · Received April 26, 1999

    Report

    Report Number
    1628664-1999-00022
    Event Type
    Other
    Date Received
    April 26, 1999
    Date of Event
    March 23, 1999
    Report Date
    April 23, 1999
    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

    ACCOUNT REPORTED AN INITIAL AXSYM B-HCG RESULT OF 4483 MLU/ML. THE RESULT WAS QUESTIONED AND UPON REPEAT WAS 31,235 MLU/ML. THERE WAS NO REPORT OF IMPACT ON PT MGMT. NO FURTHER INFO WAS AVAILABLE ON THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR ABBOT AXSYM B-HCG REAGENT LIST #7A59.