BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 1982537 · Received January 11, 2011

    Report

    Report Number
    1826988-2010-00876
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 219 MG/DL FROM HIS CONTOUR METER AND A READING OF 90 MG/DL USING ANOTHER METER. 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. CONTROL SOLUTION WAS SENT FOR FURTHER TROUBLESHOOTING. NO PRODUCT WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NBW BAYER HEALTHCARE, LLC 7184A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK