BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1040684 · Received May 8, 2008

    Report

    Report Number
    1826988-2008-00493
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 14, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE PERFORMED A BLOOD GLUCOSE TEST USING HER 2 CONTOUR METERS. THE CUSTOMER'S OLDER METER READ 12 MG/DL, WHILE THE NEW METER READ 172 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. ON ANOTHER OCCASION, THE OLDER METER READ "LO" WHILE THE OTHER METER READ 295 MG/DL. THE DIFFERENCE BETWEEN THOSE READINGS FALLS IN THE "D" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS AND METER ARE TO BE RETURNED FOR EVAL. 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 7KC3D09

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK