BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1163684 · Received September 9, 2008

    Report

    Report Number
    1826988-2008-01026
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 25, 2008
    Manufacturer
    BAYER HEALTHCARE LLC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS TESTED USING A LAB TEST AND THE RESULT WAS 89 MG/DL. HER GLUCOSE WAS RETESTED WITHIN 10 MINUTES USING HER CONTOUR METER AND THE READING WAS 224 MG/DL. THE DIFFERENCE BETWEEN 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. THE ADVOCATE 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 7MC3C01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK