BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1111004 · Received August 8, 2008

    Report

    Report Number
    1826988-2008-00844
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 10, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THAT THE CUSTOMER TESTED HER GLUCOSE AND RECEIVED A READING OF MORE THAN 300 MG/DL USING HER CONTOUR METER. THE ADVOCATE ALLEGED THAT THE CUSTOMER MEDICATED AS A RESULT OF THE HIGH READING AND BECAME HYPOGLYCEMIC. THE ADVOCATE STATED THAT THE CUSTOMER WAS ABLE TO RECOVER AT HOME AND DID NOT REQUIRE OUTSIDE MEDICAL ATTENTION. TROUBLESHOOTING WAS NOT POSSIBLE AS THE ADVOCATE DID NOT HAVE TEST STRIPS OR CONTROL SOLUTION. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 7151B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention