BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1040223 · Received May 8, 2008

    Report

    Report Number
    1826988-2008-00487
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 10, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED, THAT SHE TESTED HER BLOOD GLUCOSE AND REC'D A READING OF 162 MG/DL. PARAMEDICS WERE CALLED, AND THEY TESTED THE CUSTOMER'S GLUCOSE AT 26 MG/DL USING THEIR METER. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "E" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. THE CUSTOMER WAS TREATED WITH GLUCOSE. THE TEST STRIP AND METER WERE TO BE RETURNED FOR EVAL, BUT ONLY THE METER WAS REC'D. 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 7151B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention