BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 1854415 · Received September 29, 2010

    Report

    Report Number
    1826988-2010-00671
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 19, 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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REC'D A BLOOD GLUCOSE READING OF 36 MG/DL FROM HER CONTOUR AND A READING OF 129 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. CONTROL SOLUTION WAS SENT TO THE CUSTOMER FOR FURTHER TROUBLESHOOTING. NO PRODUCT WILL BE RETURNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NBW BAYER HEALTHCARE LLC 7151G NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK