BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 998383 · Received February 8, 2008

    Report

    Report Number
    1826988-2008-00161
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 23, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE PERFORMED COMPARISON TESTS USING HER CONTOUR METER AND ANOTHER METER. THE CONTOUR READ 221, 164, AND 151 MG/DL. THE OTHER METER READ 109, 75, AND 61 MG/DL. THE DIFFERENCES 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 ANY TEST STRIPS LEFT, SO TROUBLESHOOTING WAS NOT POSSIBLE. THE METER IS TO BE RETURNED FOR EVAL. A NEW CONTOUR METER KIT WAS 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