BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2050535 · Received March 16, 2011

    Report

    Report Number
    1826988-2011-00149
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 22, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT SHE PERFORMED A CONTROL TEST USING HER CONTOUR SYSTEM AND RECEIVED A RESULT OF 275 MG/DL. THE NORMAL CONTROL RANGE WAS NOT PROVIDED, BUT SHOULD BE AROUND 106-147 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER HAD TO GO TO AN APPOINTMENT, SO SHE WAS UNABLE TO TROUBLESHOOT DURING THE CALL. CUSTOMER SERVICE ATTEMPTED TO CALL THE CUSTOMER BACK SEVERAL TIMES AFTER THE INITIAL CALL, BUT THEY WERE UNABLE TO SPEAK TO HER. NO PRODUCT WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NBW BAYER HEALTHCARE, LLC 7189 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK