BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXSYM CK-MB REAGENT

    MDR report key: 109737 · Received July 17, 1997

    Report

    Report Number
    2623532-1997-00020
    Event Type
    Other
    Date Received
    July 17, 1997
    Date of Event
    June 16, 1997
    Report Date
    July 17, 1997
    Manufacturer
    ABBOTT HEALTH PRODUCTS, INC.
    Product Code
    JHS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 6/16/1997 THE ACCOUNT REPORTED AN ERRATIC CK-MB RESULT ON FOR A PT, WHO LATER WAS REPORTED TO HAVE EXPIRED. THE ACCOUNT EXPERIENCED A POWER BLINK WHILE THE PT'S SAMPLE WAS RUNNING. THE INSTRUMENT DID NOT STOP RUNNING, GENERATE AN ERROR CODE OR HAVE ANY RESULTS GO TO EXCEPTIONS. A CK-MB RESULT OF 5.7 NG/ML WAS REPORTED AT 9:45/9:54 AM AND QUESTIONED BY THE PHYSICIAN. WHEN THE SAMPLE WAS RETESTED, A RESULT OF 57 NG/ML WAS GIVEN AT 11:40 AM AND A CORRECTED REPORT WAS GENERATED. SERIAL SAMPLES WERE BEING RUN ON THE PT FOR CPK AND CK-MB AND THE RESULTS ARE PROVIDED IN SECTION B6. THE 15:00 SAMPLE WAS THE FINAL SAMPLE DRAWN FROM THE PT, HOWEVER THE TIME OF DEATH IS UNKNOWN. FURTHER INFO HAS BEEN REQUESTED FROM THE ACCOUNT, BUT HAS NOT BEEN RECEIVED, TO DETERMINED IF THERE WAS A RELATIONSHIP BETWEEN THE REPORTED ERRATIC RESULT AND THE PT'S DEATH.

    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 27088Q101

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other AXSYM ANALYZER, LIST NUMBER 7A83-01