BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 123593 · Received September 25, 1997

    Report

    Report Number
    1628664-1997-00080
    Event Type
    Other
    Date Received
    September 25, 1997
    Date of Event
    August 26, 1997
    Report Date
    September 23, 1997
    Manufacturer
    ABBOTT MFG., INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 8/26/97 THE ACCOUNT REPORTED AN ERRATIC PHENYTOIN RESULT OF 1.8 MG/L, WHICH WAS RUN ON THE AXSYM ANALYZER. THE RESULT WAS QUESTIONED BY THE PHYSICIAN. RETEST RESULTS WERE 30.7MG/L AND 30.4 MG/L. THE PT WAS NOT TREATED BASED UPON THE FIRST REPORTED RESULT. NO REPORT OF INJURY. ACCORDING TO THE CUSTOMER, THE MESSAGE HISTORY LOG IDENTIFIED SEVERAL LLS ERRORS FOR THE PROCESSING PROBE. THE ACCOUNT CHECKED THE PROCESSING PROBE AND NOTICED THAT THE TEFLON WAS DAMAGED. THE ACCOUNT CHANGED THE PROBE AND CALIBRATED IT.

    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 61 YR AXSYM PHENYTOIN REAGENT, LIST NUMBER 7A67-20.| AXSYM PROBE, LIST NUMBER 9A59-01.