BEUDAMED
    FDA Adverse Event Summary report: N

    PROFILER

    MDR report key: 1754003 · Received June 23, 2010

    Report

    Report Number
    1754003
    Date Received
    June 23, 2010
    Date of Event
    June 3, 2010
    Report Date
    June 22, 2010
    Manufacturer
    BIOSITE INCORPORATED DBA INNOVACON INCORPORATED
    Product Code
    NBC
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    TESTING PERFORMED ON BIOSITE CARDIAC MARKER DEVICE (METER CONTROL VERSION:5.02.028). TEST RESULTS WERE SENT ACROSS INTERFACE AND POSTED ON PATIENT RECORD AS P TNI 0.06; P BNP 147 .OH; P CKMB-4.0; P MYO 289.OH. PRINTOUT SHOWED A BACKLIT "LOW" RESULT OVERLAYING EACH RESULT. NO NUMERIC RESULTS DISPLAYED. TESTS WERE REPEATED AND RESULTS WERE: P TNI 0.31, P BNP 353.OH, P CKMB 8.2 ,P MYO 186.OH. INFORMATION HAS BEEN REPORTED TO BIOSITE WHO IS INVESTIGATING THE REASON FOR THE "LOW" MESSAGE DISPLAYED ON THE METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILER BNP; TEST,NATRIURETIC PEPTIDE NBC BIOSITE INCORPORATED DBA INNOVACON INCORPORATED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR