BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 3040473 · Received April 8, 2013

    Report

    Report Number
    1826988-2013-00144
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 14, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SECOND LOT# OF TEST STRIPS WAS RETURNED TO QA FOR EVALUATION: BREEZE2 TEST STRIPS: PRODUCT INFORMATION : MODEL # NOT PROVIDED LOT# 1A6343AA, EXP. DATE 04/30/2014. DATE RETURNED TO MANUFACTURER: (B)(4) 2013. DEVICE MANUFACTURE DATE:) 10/012012. 510(K) 062347.

    Description of Event or Problem · 1

    THE ADVOCATE STATED HIS WIFE RECEIVED A BLOOD GLUCOSE READING OF 15MG/DL FROM THE BREEZE2 METER, RE-TESTED ON A CONTOUR METER AND RECEIVED 329MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "E" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED THE TEST STRIPS WERE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS AND METER WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143649 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7080G 2EC3A04

    Patients

    Seq Age Sex Outcome Treatment
    1