BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 154346 · Received March 2, 1998

    Report

    Report Number
    1628664-1998-00016
    Event Type
    Other
    Date Received
    March 2, 1998
    Date of Event
    February 2, 1998
    Report Date
    February 26, 1998
    Manufacturer
    ABBOTT MFG., INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 2/2/1998 THE ACCOUNT REPORTED AN ERRATIC VALPROIC ACID RESULT OF 1.21 MG/L, WHICH WAS RUN ON THE AXSYM ANALYZER. A FLAG WAS NOT GIVEN WITH THE ERRATIC RESULT. THE RESULT WAS QUESTIONED BY THE NURSE AND THE SAMPLE WAS RETESTED, GIVING 96.75 MG/L. ACCORDING TO THE ACCOUNT, THE SAMPLE WAS TESTED BOTH TIMES IN THE PRIMARY TUBE. TREATMENT WAS NOT GIVEN BASED UPON THE FIRST REPORTED RESULT.

    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 34 YR AXSYM VALPROIC ACID REAGENT, LIST NUMBER 7A71-20.