BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 99983 · Received June 18, 1997

    Report

    Report Number
    1628664-1997-00058
    Event Type
    Other
    Date Received
    June 18, 1997
    Date of Event
    May 22, 1997
    Report Date
    June 18, 1997
    Manufacturer
    ABBOTT MFG., INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 5/22/97 AN ERRATIC PHENYTOIN RESULT WAS REPORTED, WHICH WAS RUN ON THE AXSYM ANALYZER. AN INITIAL RESULT OF 6.47 MG/L WAS REPORTED AND QUESTIONED. THE SAMPLE WAS RERUN AND A RESULT OF 24.4 MG/L WAS RECEIVED. MEDICAL INTERVENTION WAS NOT WITHHELD OR DELAYED BASED ON THE FIRST REPORTED RESULT. NO REPORT OF INJURY. THE SAMPLE HAD BEEN PREVIOUSLY FROZEN AND WAS RUN IN THE PRIMARY TUBE. UPON REINSPECTION OF THE SAMPLE AFTER THE FIRST RUN, THE ACCOUNT NOTICED A BUBBLE ON TOP OF THE PRIMARY TUBE. THE MESSAGE HISTORY LOG HAD ALSO REVEALED A PROBE CRASH ON 5/15/97. ACCORDING TO THE ACCOUNT, THE SAMPLE PROBE WAS RECALIBRATED BUT NOT REMOVED AND INSPECTED FOR DAMAGE. THE CUSTOMER STATED THAT THE PROBE TIP WAS MISSING TEFLON. CUSTOMER SERVICE INSTRUCTED THE ACCOUNT TO CHANGE AND REPLACED THE SAMPLE PROBE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR AXSYM PHENYTOIN REAGENT, LIST NUMBER, 7A67-20