BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR USB

    MDR report key: 1960162 · Received December 15, 2010

    Report

    Report Number
    1826988-2010-00853
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K091820
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 340 MG/DL FROM HIS CONTOUR USB METER AND A READING OF 164 MG/DL FROM ANOTHER METER. 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. NO PRODUCT WILL BE RETURNED.

    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