BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 115349 · Received August 14, 1997

    Report

    Report Number
    1628664-1997-00072
    Event Type
    Other
    Date Received
    August 14, 1997
    Date of Event
    July 4, 1997
    Report Date
    August 14, 1997
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON OR AROUND 07/04/1997 THE ACCOUNT REPORTED A FALSELY ELEVATED CK-MB RESULT OF 40 NG/ML ON A PT SAMPLE, WHICH WAS RUN ON THE AXSYM ANALYZER AT 09:00 A.M. THE PTS TOTAL CPK WAS 51 AND THE DR QUESTIONED THE CK-MB RESULT. THE ERRATIC RESULT WAS GIVEN FROM AN ALIQUOT TUBE THAT WAS POURED FROM THE PRIMARY TUBE. ACCORDING TO THE ACCOUNT, A NEW ALIQUOT TUBE WAS POURED FROM THE PRIMARY TUBE AND BOTH ALIQUOT TUBES WERE TESTED AT 13:15 PM. RESULTS OF 2.4 AND 2.3 NG/ML WERE GIVEN. AN AMENDED REPORT WAS SENT OUT. NO REPORT OF INJURY. FOLLOW-UP INFO RECD FROM THE ACCOUNT INDICATED A QUESTION OF SAMPLE INTEGRITY.

    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 88 YR AXSYM CK-MB REAGENT, LIST 7A57-20.