BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 1935123 · Received December 6, 2010

    Report

    Report Number
    1826988-2010-00820
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HER BLOOD GLUCOSE USING HER 2 CONTOUR METERS AND RECEIVED READINGS OF 525 AND 107 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "D" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER PERFORMED A CONTROL TEST DURING THE CALL AND THE RESULT FELL WITHIN THE NORMAL CONTROL RANGE. NO PRODUCT WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NBW BAYER HEALTHCARE, LLC 9678 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK