BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1001234 · Received February 15, 2008

    Report

    Report Number
    1826988-2008-00224
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 8, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THAT THE CUSTOMER TESTED HER BLOOD GLUCOSE AND RECEIVED A READING OF MORE THAN 300 MG/DL USING HER CONTOUR METER. THE CUSTOMER RETESTED USING THE ADVOCATE'S CONTOUR METER AND RECEIVED A READING OF MORE THAN 100 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 EVAL. REPLACEMENT TEST STRIPS 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 7099B 6KC3D05

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK