BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1053390 · Received May 22, 2008

    Report

    Report Number
    1826988-2008-00532
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 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 CUSTOMER STATED THAT HE TESTED HIS BLOOD GLUCOSE USING A CONTOUR METER AND AN ELITE METER. THE CONTOUR METER READ IN THE 300'S (MG/DL), WHILE THE ELITE READ 160 MG/DL. IF THE CONTOUR METER READ 319 MG/DL OR HIGHER, THE DIFFERENCE BETWEEN THE METER READINGS WOULD FALL IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS WERE 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 NOT PROVIDED 7KC3C01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK