BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR

    MDR report key: 4140714 · Received October 3, 2014

    Report

    Report Number
    1826988-2014-00342
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 13, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADVOCATE STATED HER SON RECEIVED EVENING BLOOD GLUCOSE READINGS OF 319 AND 322MG/DL ON THE CONTOUR METER. HE TOOK HIS INSULIN AND DID NOT EAT. THE NEXT MORNING SHE WITNESS HER SON FALLING OFF OF THE COUCH, HAVING A SEIZURE. SHE ATTEMPTED TO GIVE HIM COKE TO DRINK. ADDITIONAL BLOOD TESTS ON THE METER, AFTER THE SEIZURE WERE, 75, 257 AND 200MG/DL. THERE WAS NO MENTION OF ADDITIONAL TREATMENT. THE TEST STRIPS ARE EXPECTED TO BE RETURNED FOR EVALUATION. NEW METER AND STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619926 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7080G 4AJ3D01

    Patients

    Seq Age Sex Outcome Treatment
    1