BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2615513 · Received June 5, 2012

    Report

    Report Number
    1826988-2012-00310
    Event Type
    Malfunction
    Date Received
    June 5, 2012
    Date of Event
    April 30, 2012
    Report Date
    April 30, 2012
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A CONTROL READING OF 55 MG/DL ON HER CONTOUR METER. THE RANGE WAS 101-104 MG/DL. NO AE WAS ALLEGED. NEW TEST STRIPS WERE SENT TO THE CUSTOMER AND SHE IS EXPECTED TO RETURN HER STRIPS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS NBW BAYER HEALTHCARE, LLC 7080G 1LC3A09A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK