BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXSYM CK-MB REAGENT

    MDR report key: 86124 · Received April 18, 1997

    Report

    Report Number
    2623532-1997-00012
    Event Type
    Other
    Date Received
    April 18, 1997
    Date of Event
    March 14, 1997
    Report Date
    April 17, 1997
    Manufacturer
    ABBOTT HEALTH PRODUCTS, INC.
    Product Code
    JHS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 3/14/97, THE ACCOUNT REPORTED A DISCREPANT RESULT FOR CK-MB, WHICH WAS RUN ON THE ANALYZER. THE PT WAS PRESENTED IN ER WITH TIGHTNESS IN THE CHEST. A CK-MB RESULT OF 20.7 NG/ML WAS REPORTED ALONG WITH A TOTAL CPK (METHOD UNKNOWN) RESULT OF 326. THE CK-MB RESULT WAS QUESTIONED BY THE CARDIOLOGIST IN ER AND SENT OUT TO A REFERENCE LAB FOR ELECTROPHORESIS. A RESULT OF 3.7% WAS OBTAINED (0-5% IS THE NORMAL RANGE). BECAUSE OF THE FIRST REPORTED CK-MB RESULT, THE PT WAS ADMITTED AND PUT IN THE INTENSIVE CARE UNIT. SHE WAS PLACED ON TELEMETRY AND SERIAL ENZYMES WERE ORDERED. THE PT WAS RELEASED FROM THE HOSP ON 3/18/97 AFTER THE ELECTROPHORESIS RESULT WAS RECEIVED. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM CK-MB REAGENT MEIA FOR THE MEASUREMENT OF CK-MB JHS ABBOTT HEALTH PRODUCTS, INC. NA 25274Q100

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR AXSYM ANALYZER, LIST #7A83-01