BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2231262 · Received July 25, 2011

    Report

    Report Number
    1826988-2011-00436
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HIS BLOOD GLUCOSE USING HIS CONTOUR METER AND RECEIVED A READING OF 118 MG/DL. HE RETESTED USING ANOTHER METER AND RECEIVED A READING OF "LOW". 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. CONTROL SOLUTION WAS SENT TO THE CUSTOMER 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 9545C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK