BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2666515 · Received July 13, 2012

    Report

    Report Number
    1826988-2012-00366
    Event Type
    Malfunction
    Date Received
    July 13, 2012
    Date of Event
    May 1, 2012
    Report Date
    June 19, 2012
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A CONTROL RESULT OF 332 MG/DL ON HER CONTOUR METER. THE NORMAL CONTROL RANGE WAS 103-142 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. REPLACEMENT STRIPS WERE SENT TO THE CUSTOMER AND SHE IS EXPECTED TO RETURN HER STRIPS FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS NBW BAYER HEALTHCARE, LLC 7080G 1DC3A03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK