BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 233291 · Received July 22, 1999

    Report

    Report Number
    1628664-1999-00039
    Event Type
    Other
    Date Received
    July 22, 1999
    Date of Event
    June 23, 1999
    Report Date
    July 21, 1999
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    LCI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER EXPERIENCING ERRATIC RESULTS WITH VALPROIC ACID. ON 6/23/99 CUSTOMER OBTAINED A RESULT OF 0.56UG/ML. RESULT WAS QUESTIONED BY PHYSICIAN, SAMPLE WAS RERUN WITH A RESULT OF 75.OUG/ML. CUSTOMER IS NOT SURE IF TUBE CONTAINED FIBRIN. NO REPORT OF IMPACT TO PATIENT.

    Description of Event or Problem · 2

    CUSTOMER OBTAINED A VALPROIC ACID RESULT OF 7.9UG/ML, RESULT WAS QUESTIONED BY PHYSICIAN. SAMPLE WAS RERUN WITH A RESULT OF 66.9UG/ML. PHYSICIAN QUESTIONED RESULT PRIOR TO TREATING PATIENT. NO REPORT OF INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR AXSYM VALPROIC ACID ASSAY LIST NUMBER 7A71-20.
    2 19 YR