BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 252547 · Received November 29, 1999

    Report

    Report Number
    1628664-1999-00064
    Event Type
    Other
    Date Received
    November 29, 1999
    Report Date
    November 23, 1999
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A VALPROIC ACID RESULT WAS REPORTED WITHIN LAST YEAR OF 6-7MG/L TO PHYSICIAN. THE PHYSICIAN QUESTIONED RESULTS AND REQUESTED SAMPLE BE RETESTED. RETEST REPEATED TWO TIMES WITH A RESULT OF 40MG/L BEING REPORTED.CUSTOMER DECLINED TO PROVIDE ANY PATIENT INFORMATION. NO REPORT OF INJURY OR IMPACT TO PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA LIST NUMBER 7A71.| AXSYM VALPROIC ACID ASSAY