BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 3090487 · Received May 2, 2013

    Report

    Report Number
    1826988-2013-00201
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER INFORMATION AND PRODUCT INFORMATION (D4) COULD NOT BE OBTAINED. IT'S NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE WITHOUT THE PRODUCT INFORMATION.

    Description of Event or Problem · 1

    THE ADVOCATE STATED THE CUSTOMER TESTED HIS BLOOD GLUCOSE USING 2 CONTOUR METERS AND RECEIVED READINGS OF 194 AND 94 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE METER AND ACCESSORIES WERE NOT AVAILABLE DURING THE CALL SO NO INFORMATION WAS OBTAINED. NO PRODUCT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192976 CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1