BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 3090450 · Received May 2, 2013

    Report

    Report Number
    1826988-2013-00199
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SECOND LOT# OF TEST STRIPS, THAT WAS NOT INCLUDED IN THE INITIAL REPORT, WAS RETURNED ON (B)(4) 2013 AND EVALUATED. CONTOUR TEST STRIPS. PRODUCT INFORMATION: MODEL 7080G, LOT# 2EC3A04, EXP. DATE 05/31/2014. DEVICE MANUFACTURE DATE: 05/01/2012. PMA 510(K) 110587.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER ADDRESS AND PHONE WERE NOT PROVIDED.

    Description of Event or Problem · 1

    ADVOCATE STATED THE CUSTOMER RAN BLOOD GLUCOSE TESTS ON BOTH, THE CONTOUR LINK AND THE CONTOUR NEXT LINK. THE READINGS WERE 99 AND 188MG/DL, RESPECTIVELY. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192633 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7311 2FFED04

    Patients

    Seq Age Sex Outcome Treatment
    1