BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (100)

    MDR report key: 1212737 · Received October 20, 2008

    Report

    Report Number
    1826988-2008-01189
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE TESTED HER BLOOD GLUCOSE AND RECEIVED A READING OF 228 MG/DL USING HER CONTOUR METER. SHE WAS RETESTED WITH ANOTHER METER AND THE READING WAS 104 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS (100) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC. 7090D 7CC3C02

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK