BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 1884600 · Received October 25, 2010

    Report

    Report Number
    1826988-2010-00720
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 12, 2010
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K060470
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER'S BLOOD GLUCOSE WAS TESTED USING HER CONTOUR METER AND A LAB TEST. THE LAB TEST RESULT WAS 247 MG/DL, WHILE THE CONTOUR READ 52 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER DID NOT HAVE ANY TEST STRIPS LEFT, SO NO PRODUCT WILL BE RETURNED. A REPLACEMENT METER WAS SENT TO THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK