BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 3021049 · Received March 26, 2013

    Report

    Report Number
    1826988-2013-00113
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT INVOLVED: BRAND NAME CONTOUR NEXT TEST STRIPS. PRODUCT INFORMATION: MODEL 7311, LOT# 2FEC05, EXP. DATE 06/30/2014, DEVICE MANUFACTURE DATE: 06/01/2012. 510(K) 111268.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 140MG/DL ON THE CONTOUR METER, RE-TESTED ON THE CONTOUR NEXT EZ METER AND THE READING WAS 80MG/DL. DURING THE CALL, SHE RAN A BLOOD TEST ON THE CONTOUR AND THE READING WAS 23MG/DL, RE-TESTED ON THE CONTOUR NEXT EZ AND THE READING WAS 161MG/DL. THE DIFFERENCES BETWEEN THE READINGS FALL IN THE "C" AND "E" ZONES OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCES CLINICALLY SIGNIFICANT NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT TEST STRIPS AND NEW METERS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123786 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7080G 2BC3F01

    Patients

    Seq Age Sex Outcome Treatment
    1