BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR USB

    MDR report key: 2223313 · Received August 16, 2011

    Report

    Report Number
    1826988-2011-00472
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K091820
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HER BLOOD GLUCOSE USING HER CONTOUR USB METER AND RECEIVED A READING OF 270 MG/DL. HER GLUCOSE WAS RETESTED USING ANOTHER METER AND THAT READING WAS 110 MG/DL. THE DIFFERENCE BETWEEN THE READING FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. NO PRODUCT WILL BE RETURNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR USB NBW BAYER HEALTHCARE LLC 7390 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK