BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR

    MDR report key: 2863776 · Received December 10, 2012

    Report

    Report Number
    1826988-2012-00644
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A READING OF 150MG/DL FROM HER CONTOUR METER. THIRTY MINUTES LATER, SHE RAN ANOTHER BLOOD TEST ON THE METER AND RECEIVED A READING OF "LO". CUSTOMER ALLEGES TO HAVE PASSED OUT BECAUSE OF THESE READINGS. ADDITIONAL INFORMATION ABOUT THE INCIDENT WAS NOT PROVIDED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS AND A NEW METER WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7080G 2BC3D02

    Patients

    Seq Age Sex Outcome Treatment
    1