BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 812508 · Received January 24, 2007

    Report

    Report Number
    1826988-2007-00051
    Event Type
    Malfunction
    Date Received
    January 24, 2007
    Date of Event
    January 11, 2007
    Report Date
    January 11, 2007
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE READINGS HAD BEEN HIGHER THAN USUAL. HE TESTED HIS BLOOD GLUCOSE USING A CONTOUR METER AND A PRECISION METER. THE CONTOUR READ AROUND 290 MG/DL WHILE THE PRECISION READ BETWEEN 130-150 MG/DL. THE DIFFERENCE BETWEEN A READING OF 290 MG/DL AND A READING BETWEEN 130-147 MG/DL FALLS IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER DECLINED TROUBLESHOOTING THE METER. NO PRODUCT WILL BE RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR