BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1071530 · Received July 3, 2008

    Report

    Report Number
    1826988-2008-00767
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 14, 2008
    Report Date
    June 14, 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 SHE TESTED HER BLOOD GLUCOSE AND RECEIVED READINGS OF 260 AND 240 MG/DL USING HER CONTOUR METER. SHE RETESTED USING ANOTHER METER AND RECEIVED READINGS OF 112 AND 110 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER DID NOT HAVE HER TEST STRIPS WITH HER AT THE TIME OF THE CALL, BUT THEY ARE TO BE RETURNED WITH THE METER FOR EVAL. REPLACEMENT PRODUCTS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC. 7151A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK