BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR

    MDR report key: 2862712 · Received December 10, 2012

    Report

    Report Number
    1826988-2012-00641
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 18, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 235MG/DL ON HIS CONTOUR METER AND ADMINISTERED INSULIN ACCORDINGLY. HE THEN EXPERIENCE HYPOGLYCEMIC SYMPTOMS AND HAD TO EAT SOMETHING. THE CUSTOMER HAD TAKEN ANOTHER BLOOD TEST ON THE CONTOUR SOMETIME AFTER THE INSULIN INJECTION AND THE READING WAS IN THE 70'S MG/DL. HE DID NOT REQUIRE MEDICAL ATTENTION. CUSTOMER IS TO RETURN THE TEST STRIPS FOR EVALUATION. NEW METER AND STRIPS WERE SENT TO HIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7098C 2DC3D01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention