BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR

    MDR report key: 1770180 · Received July 20, 2010

    Report

    Report Number
    1826988-2010-00476
    Event Type
    Injury
    Date Received
    July 20, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 12, 2010
    Manufacturer
    BAYER HEALTHCARE, LLC.
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER HAD TAKEN HER BLOOD GLUCOSE TEST ON HER CONTOUR METER AND STATES THE READING WAS "NORMAL." SHE THEN WENT TO THE DOCTOR'S OFFICE FOR A TEST AND READING WAS 111MG/DL. DRIVING HOME, SHE BECAME DISORIENTED AND AN AMBULANCE ARRIVED BECAUSE SHE COULD NOT GET OUT OF THE CAR. HER BLOOD GLUCOSE WAS TAKEN AND RESULT WAS 27 MG/DL. THERE WAS NO DATA TO ALLEGE THERE WAS A PRODUCT PROBLEM. NO FURTHER INFO OBTAINED. NO PRODUCT REPLACED AND NOTHING TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NBW BAYER HEALTHCARE, LLC. 7151A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other