BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMUNO I

    MDR report key: 187409 · Received September 10, 1998

    Report

    Report Number
    1810909-1998-00008
    Event Type
    Malfunction
    Date Received
    September 10, 1998
    Date of Event
    July 10, 1998
    Report Date
    September 9, 1998
    Manufacturer
    BAYER CORP.
    Product Code
    JJF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    AN INDIVIDUAL PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAINS. THE CARDIOLOGISTS ORDERED A BATTERY OF TESTS, INCLUDING CREATININE KINASE MYOCARDIAL BANDS. THE TEST WAS ASSAYED ON THE IMMUNO I USING A PLASMA SPECIMEN. THE REPORTED RESULT WAS 11.75 NG/ML. BASED ON THE RESULT THE PT WAS SENT TO CARDIAC CATHETERIZATION LAB FOR CATHETERIZATION. THE LABORATORY MEDICAL TECHNOLOGIST QUESTED THE RESULTS AFTER REVIEW OF THE TOTAL CREATININE KINASE WHICH WAS NORMAL. (THIS CAUSED DOUBT ABOUT THE CREATININE KINASE MYOCARDIAL BANDS RESULT). THEREFORE, THE TEST WAS REPEATED IN TRIPLICATE AND THE RESULTS WERE NORMAL. HOWEVER, THE PT WAS EXPOSED TO THE CATHERIZATION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMUNO I CHEMISTRY ANALYZER JJF BAYER CORP. 145 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN