BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1030405 · Received April 15, 2008

    Report

    Report Number
    1826988-2008-00446
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    April 6, 2008
    Report Date
    April 6, 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 HIS BLOOD GLUCOSE WAS TESTED USING HIS CONTOUR AND ANOTHER CONTOUR METER. THE CUSTOMER'S CONTOUR READ 567 MG/DL WHILE THE OTHER CONTOUR READ 147 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 DECLINED TO TROUBLESHOOT AND INSISTED HIS METER BE REPLACED. THE METER IS TO BE RETURNED FOR EVALUATION. A NEW 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 7151B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK