BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 3070092 · Received April 22, 2013

    Report

    Report Number
    1826988-2013-00160
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K121087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTOUR BLOOD GLUCOSE TEST STRIPS WERE ALSO RETURNED AND EVALUATED.MODEL # 7080G, LOT# 2JC3F13A, EXP DATE 09/30/2014, MANUFACTURE DATE 09/01/2012, 510K 091820.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 347MG/DL ON THE CONTOUR NEXT USB METER, RE-TESTED ON CONTOUR USB METER AND THE READING WAS 155MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANTNO ADVERSE EVENT WAS ALLEGED.THE CUSTOMER RETURNED THE TEST STRIPS FOR EVALUATION.REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171591 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7313 2LFEC51

    Patients

    Seq Age Sex Outcome Treatment
    1