BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1082810 · Received July 24, 2008

    Report

    Report Number
    1826988-2008-00795
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 28, 2008
    Report Date
    June 28, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE TESTED HER BLOOD GLUCOSE USING HER CONTOUR METER AND RECEIVED A READING OF 288 MG/DL. SHE RETESTED USING ANOTHER METER AND RECEIVED A READING OF 101 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WERE ALLEGED. THE CUSTOMER USED THE LAST OF THE SUSPECT TEST STRIPS WHILE TROUBLESHOOTING, SO NO PRODUCT IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 7151B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK