BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1564855 · Received December 1, 2009

    Report

    Report Number
    1826988-2009-01043
    Event Type
    Malfunction
    Date Received
    December 1, 2009
    Date of Event
    November 23, 2009
    Report Date
    November 23, 2009
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HIS BLOOD GLUCOSE AND RECEIVED A CONTOUR READING BETWEEN 210-250 MG/DL. HE RETESTED HIS GLUCOSE USING ANOTHER METER AND THE READING WAS 130 MG/DL. IF THE CUSTOMER'S CONTOUR READ 249 OR 250 MG/DL, THE DIFFERENCE BETWEEN THE READINGS WOULD FALL IN THE "C" ZONE MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVAL. THE CUSTOMER ALSO INSISTED THE METER BE REPLACED. 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 7097C 8KC3D03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK