BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR USB

    MDR report key: 2474758 · Received March 1, 2012

    Report

    Report Number
    1826988-2012-00077
    Event Type
    Malfunction
    Date Received
    March 1, 2012
    Date of Event
    January 1, 2012
    Report Date
    February 1, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K091820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HER CONTOUR USB SYSTEM. SHE ALLEGED THAT SHE PERFORMED A CONTROL TEST PRIOR TO THE CALL AND RECEIVED A RESULT OVER 300 MG/DL. THE NORMAL CONTROL RANGE WAS NOT PROVIDED, BUT SHOULD BE AROUND 104-144 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER DECLINED TO TROUBLESHOOT BECAUSE SHE HAD AN APPOINTMENT TO ATTEND. NO PRODUCT WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR USB BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC 7390

    Patients

    Seq Age Sex Outcome Treatment
    1