BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 170972 · Received June 1, 1998

    Report

    Report Number
    1628664-1998-00045
    Event Type
    Other
    Date Received
    June 1, 1998
    Date of Event
    April 20, 1998
    Report Date
    May 28, 1998
    Manufacturer
    ABBOTT MFG, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 4/20/1998 AN ERRATIC PHENYTOIN RESULT OF 0.1 MG/L WAS REPORTED ON A PT WHO PRESENTED IN THE EMERGENCY ROOM AT THE ACCOUNT. THE EMERGENCY ROOM QUESTIONED THE RESULT AND THE SAMPLE WAS RETESTED, GIVING 16.99 MG/L. NO REPORT OF INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO AXSYM PHENYTOIN REAGENT, LIST NUMBER 7A67-20.