BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 226833 · Received June 1, 1999

    Report

    Report Number
    1628664-1999-00028
    Event Type
    Other
    Date Received
    June 1, 1999
    Date of Event
    April 29, 1999
    Report Date
    May 28, 1999
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 04/29/99 THE ACCOUNT REPORTED AN AXSYM VALPROIC ACID OF 0.9 UG/ML. THE ACCOUNT ACCIDENTALLY REPEATED THE SAME SAMPLE AND OBTAINED 70.74 UG/ML. THE SAMPLE WAS REPEATED 2 MORE TIMES AND RESULTS WERE 72.49 UG/ML AND 71.79 UG/ML. AN AMENDED REPORT WAS SENT WITH AN AVERAGE RESULT OF 72.0 UG/ML REPORTED. NO REPORT OF INJURY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM AUTOMATED SYSTEM FOR THE PROCESSING OF EIAS JJE ABBOTT LABORATORIES, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR ABBOTT AXSYM VALPROIC ACID REAGENT LIST # 7A71.