BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR

    MDR report key: 3090455 · Received May 2, 2013

    Report

    Report Number
    1826988-2013-00191
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110587
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 128MG/DL ON HER CONTOUR LINK AT 7:30AM. LATER IN CHURCH, SHE FELT HER BLOOD GLUCOSE WAS LOW, SO SHE TOOK ONE GLUCOSE TABLET, CONTINUED TO FEEL LOW, AND WHILE WALKING TO HER CAR TO TEST HER BLOOD SHE PASSED OUT. SOMEONE HAD TO DRIVE HER HOME. AFTER SHE HAD EATEN THE GLUCOSE TABLET SHE TESTED HER BLOOD ON THE CONTOUR LINK AT 9:10AM AND THE READING WAS 143MG/DL. SHE ALSO CHECKED THE " SENSOR" SHE WAS WEARING WITH HER INSULIN PUMP, AND THE READING WAS 55MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "D" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT . THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. BOTH METER AND STRIPS WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193201 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7098B 2LC3F06

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention