BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 3042104 · Received April 9, 2013

    Report

    Report Number
    1826988-2013-00142
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL RECEIVED CONSECUTIVE BLOOD GLUCOSE READINGS OF 506MG/DL ON THE CONTOUR METER, RE-TESTED THE PATIENT ON A DIFFERENT METER AND THE CONSECUTIVE READINGS WERE 52 AND 53MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "D" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT NO 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
    145334 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 2JC3F02

    Patients

    Seq Age Sex Outcome Treatment
    1