BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2874514 · Received December 14, 2012

    Report

    Report Number
    1826988-2012-00659
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 29, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTOUR NEXT TEST STRIPS WERE ALSO RETURNED AND EVALUATED: MODEL NUMBER WAS NOT PROVIDED. LOT# 2FFEC05, EXP DATE 07/31/2014. MANUFACTURE DATE 07/01/2012; 510(K) # 110894.

    Description of Event or Problem · 1

    THE CUSTOMER RAN HER BLOOD GLUCOSE TEST ON THE CONTOUR NEXT LINK AND THE CONTOUR METERS. THE READINGS WERE 38 AND 173MG/DL, RESPECTIVELY. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "D" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS WERE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7080G 2GC3F02

    Patients

    Seq Age Sex Outcome Treatment
    1