BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1507679 · Received September 30, 2009

    Report

    Report Number
    1826988-2009-00856
    Event Type
    Malfunction
    Date Received
    September 30, 2009
    Date of Event
    September 17, 2009
    Report Date
    September 17, 2009
    Manufacturer
    BAYER HEALTHCARE, LLC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HIS BLOOD GLUCOSE AND RECEIVED READINGS OF 215, 220, 222 AND 195 MG/DL USING HIS CONTOUR METER. HE RETESTED USING ANOTHER METER AND RECEIVED READINGS OF 107 AND 99 MG/DL. THE DIFFERENCE BETWEEN SOME OF THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN HIS TEST STRIPS 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. 7097C 8LC3D04

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK