BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR USB

    MDR report key: 3090412 · Received May 2, 2013

    Report

    Report Number
    1826988-2013-00183
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 6, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K091820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HER BLOOD GLUCOSE USING 2 CONTOUR USB METERS AND RECEIVED READINGS OF 59 AND 120MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. ONLY THE METER INFORMATION WAS PROVIDED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. NEW METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191986 CONTOUR USB BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC 7393A

    Patients

    Seq Age Sex Outcome Treatment
    1