BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2690279 · Received August 10, 2012

    Report

    Report Number
    1826988-2012-00432
    Event Type
    Malfunction
    Date Received
    August 10, 2012
    Date of Event
    July 1, 2012
    Report Date
    July 23, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER RECEIVED A CONTROL RESULT OF 300 MG/DL ON HIS CONTOUR METER. THE NORMAL CONTROL RANGE WAS 103-142 MG/DL. NO ADVERSE EVENT WAS ALLEGED. NEW STRIPS WERE SENT AND CUSTOMER RETURNED HIS STRIPS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7080G 1LC3B10

    Patients

    Seq Age Sex Outcome Treatment
    1