BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 1853326 · Received September 29, 2010

    Report

    Report Number
    1826988-2010-00683
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 12, 2010
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HER BLOOD GLUCOSE WAS TESTED USING HER CONTOUR METER AND THE READING WAS 110 MG/DL. THE HOSPITAL PERFORMED A BLOOD GLUCOSE TEST AND RECEIVED A READING OF 25 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "D" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENT CLINICALLY SIGNIFICANT. THE CUSTOMER WAS GIVEN JUICE TO RAISE HER BLOOD GLUCOSE LEVEL. THE CUSTOMER WAS ADVISED TO RETURN HER TEST STRIPS FOR EVAL. REPLACEMENT TEST STRIPS AND A NEW METER WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS NBW BAYER HEALTHCARE, LLC 7098B 9LC3D16

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention