BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 164681 · Received April 23, 1998

    Report

    Report Number
    1628664-1998-00033
    Event Type
    Other
    Date Received
    April 23, 1998
    Date of Event
    March 15, 1998
    Report Date
    April 22, 1998
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON OR AROUND 03/15/1998 THE ACCOUNT REPORTED AN ERRATIC PHENYTOIN RESULT OF <0.5 MG/L WHICH WAS RUN ON THE AXSYM ANALYZER. AN ERROR MESSAGE WAS NOT GIVEN WITH THE ERRATIC RESULT TO WARN THE USER. THE PT HAD ARRIVED AT 22:00 PM BY AMBULANCE AT THE ER WITH CONVULSIONS. THE PT WAS DOSED BASED ON THE ERRATIC RESULT AND HAD A PHENYTOIN LEVEL OF 30 MG/L AFTER RECEIVING THE DOSE. RETESTING OF THE INITIAL SAMPLE GAVE 13 MG/L. THE PT WAS DISCHARGED ON 03/16/1998.

    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 38 YR AXSYM PHENYTOIN REAGENT, LIST NUMBER 7A67-20.