BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 145036 · Received January 16, 1998

    Report

    Report Number
    1628664-1998-00003
    Event Type
    Other
    Date Received
    January 16, 1998
    Date of Event
    December 22, 1997
    Report Date
    January 15, 1998
    Manufacturer
    ABBOTT MFG, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 12/22/1997 THE ACCOUNT REPORTED A DISCREPANT RESULT OF <12.0 MG/L FOR VALPROIC ACID, WHICH WAS RUN ON THE AXSYM ANALYZER. THE SAMPLE WAS COLLECTED IN A CLOT TUBE WITH A SERUM GEL SEPARATOR AND WAS RUN IN AN ALIQUOT TUBE. AN INITIAL RESULT OF 0.0 MG/L WAS GIVEN BY THE ANALYZER. PER LAB PROTOCOL, THE SAMPLE WAS RETESTED GIVING 7.0 MG/L; A RESULT OF <12 MG/L WAS REPORTED. THE RESULT WAS QUESTIONED BY THE PHYSICIAN AND THE SAMPLE WAS RETESTED AGAIN, GIVING 86 MG/L. NO TREATMENT WAS 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 14 YR AXSYM VALPROIC ACID ASSAY, LIST NUMBER 7A71-20.