BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2326186 · Received October 14, 2011

    Report

    Report Number
    1826988-2011-00590
    Event Type
    Malfunction
    Date Received
    October 14, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 18, 2011
    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 HIS BLOOD GLUCOSE USING HIS CONTOUR METER AND RECEIVED READINGS OF 238, 248, 201, 216, 244, 218, 232 AND 264 MG/DL. HE RETESTED USING ANOTHER METER AND RECEIVED READINGS OF 132, 167, 111, 118, 141, 109, 142, 132, 108, 119 AND 136 MG/DL. THE DIFFERENCE BETWEEN SOME OF THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. CONTROL SOLUTION WAS SENT TO THE CUSTOMER. NO PRODUCT WILL BE RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK