BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1001203 · Received February 15, 2008

    Report

    Report Number
    1826988-2008-00209
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    February 4, 2008
    Report Date
    February 4, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THAT THE CUSTOMER'S GLUCOSE WAS TESTED USING HER CONTOUR METER AND ANOTHER METER. THE CONTOUR READ 211 MG/DL, WHILE THE OTHER METER READ 90 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 WAS UNABLE TO TROUBLESHOOT THE CONTOUR SYSTEM AT THE TIME OF THE CALL. NO PRODUCT WILL BE RETURNED AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK