BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR

    MDR report key: 4251599 · Received November 14, 2014

    Report

    Report Number
    1826988-2014-00406
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 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

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 112MG/DL ON THE CONTOUR METER, BUT WENT TO THE HOSPITAL BECAUSE OF HYPOGLYCEMIC SYMPTOMS. FURTHER DETAILS ABOUT THE INCIDENT AND TREATMENT WERE NOT PROVIDED. CUSTOMER RETURNED THE TEST STRIPS FOR EVALUATION. NEW METER AND STRIPS WERE SENT TO HIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738387 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7070A 4EJ3B32

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization