BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENIA CONTOUR

    MDR report key: 1163683 · Received September 9, 2008

    Report

    Report Number
    1826988-2008-01027
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 25, 2008
    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 ADVOCATE STATED THAT THE CUSTOMER TESTED HIS BLOOD GLUCOSE AND RECEIVED A READING OF 365 MG/DL, USING ONE OF HIS CONTOUR METERS. HE RETESTED WITH HIS OTHER CONTOUR AND RECEIVED A READING OF 140 MG/DL. THE DIFFERENCE BETWEEN READINGS FALLS IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER USED THE LAST OF HIS TEST STRIPS, BUT HIS METER IS TO BE RETURNED FOR EVALUATION. A REPLACEMENT METER WAS SENT TO THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK