BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR

    MDR report key: 4102825 · Received September 19, 2014

    Report

    Report Number
    1826988-2014-00316
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 23, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED AN AMBULANCE BECAUSE HE WAS FEELING LIGHT HEADED AND HAD DIFFICULTY BREATHING. HE TOOK A BLOOD TEST ON THE CONTOUR METER AND THE READING WAS 203MG/DL. EMERGENCY PERSONNEL RAN A TEST ON THEIR METER AND THE READING WAS 650MG/DL. THE CUSTOMER WAS TAKEN TO THE HOSPITAL AND WAS GIVEN INSULIN INJECTIONS AND INSULIN DRIP. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT TEST STRIPS AND NEW METER WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583997 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7080G 4CJ3D03

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R