BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 173809 · Received June 19, 1998

    Report

    Report Number
    1628664-1998-00057
    Event Type
    Other
    Date Received
    June 19, 1998
    Date of Event
    May 12, 1998
    Report Date
    June 12, 1998
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 05/12/1998 THE ACCOUNT REPORTED A FALSE NEGATIVE "CMV-G" ON A KNOWN POSITIVE DONOR, WHICH WAS RUN ON THE AXSYM ANALYZER. THE SAMPLE WAS RETESTED AND A RESULT OF 238.8 AU/ML WAS RECEIVED. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO AXSYM CMV-G REAGENT, 4B47-20.