BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 507594 · Received December 23, 2003

    Report

    Report Number
    1628664-2003-00017
    Event Type
    Other
    Date Received
    December 23, 2003
    Date of Event
    November 9, 2003
    Report Date
    December 17, 2003
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JHE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN LOT NUMBER 08109Q100.| AXSYM TOTAL BHCG REAGENT LIST NUMBER 7A59-22,