BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR LINK

    MDR report key: 2213856 · Received August 4, 2011

    Report

    Report Number
    1826988-2011-00453
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 14, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN SOME COUNTRIES OUTSIDE THE UNITED STATES, CUSTOMER INFORMATION IS NOT PROVIDED TO PRIVACY LAWS. SINCE THE SERIAL NUMBER OF THE CUSTOMER'S METER COULD NOT BE OBTAINED, IT WAS NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE.

    Description of Event or Problem · 1

    A SALES REPRESENTATIVE IN (B)(4) CONTACTED CUSTOMER SERVICE AFTER RECEIVING AN EMAIL ABOUT A CUSTOMER WHO WAS HAVING CONTOUR LINK METER ISSUES. ON (B)(6), THE CUSTOMER RECEIVED A HIGH GLUCOSE READING AND A CONTROL TEST RESULT OF 2.45 G/L (245 MG/DL). ON (B)(6), A CONTROL TEST RESULT OF 3.52 G/L (352 MG/DL) WAS RECEIVED. A NORMAL CONTROL RANGE WAS NOT ABLE TO BE PROVIDED, BUT SHOULD BE AROUND 1.06-1.47 G/L (106-147 MG/DL). NO ADVERSE EVENTS WERE ALLEGED. THE SALES REPRESENTATIVE WAS TO GET THE CUSTOMER'S PRODUCTS AND RETURN THEM TO THE UNITED STATES FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR LINK NBW BAYER HEALTHCARE, LLC 7778 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK