BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2000499 · Received January 31, 2011

    Report

    Report Number
    1826988-2011-00040
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 23, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THE CUSTOMER'S GLUCOSE WAS TESTED USING 2 DIFFERENT CONTOUR METERS AND THE READINGS WERE 15, 33 AND 473 MG/DL. THE DIFFERENCE BETWEEN THE HIGH AND LOW READINGS FALLS IN THE "E" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. IT'S NOT KNOWN WHICH READINGS CAME FROM WHICH METER. CONTROL SOLUTION WAS SENT FOR FURTHER TROUBLESHOOTING, SO NO PRODUCT WILL BE RETURNED AT THIS TIME. REPLACEMENT METERS WERE SENT TO THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK