BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1210281 · Received October 20, 2008

    Report

    Report Number
    1826988-2008-01237
    Event Type
    Injury
    Date Received
    October 20, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE TESTED HER BLOOD GLUCOSE ONE MORNING AND RECEIVED A READING OF 145 MG/DL USING HER CONTOUR METER. A HALF HOUR AFTER TESTING HER GLUCOSE THE CUSTOMER PASSED OUT. SHE REGAINED CONSCIOUSNESS A FEW HOURS AFTER SHE PASSED OUT, AND CALLED PARAMEDICS. PARAMEDICS TESTED THE CUSTOMER'S GLUCOSE AT 30 MG/DL USING THEIR METER. THE CUSTOMER WAS TREATED WITH GLUCOSE. THE CUSTOMER PERFORMED CONTROL TESTS WHILE TROUBLESHOOTING AND THE RESULTS WERE WITHIN THE NORMAL CONTROL RANGE. THE METER AND TEST STRIPS ARE STILL TO BE RETURNED FOR EVALUATION. REPLACEMENT PRODUCTS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 7080D 8CC3B06

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention