BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 1884660 · Received October 25, 2010

    Report

    Report Number
    1826988-2010-00732
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 14, 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 ALLEGED THAT SHE PERFORMED A CONTROL TEST USING HER CONTOUR SYSTEM AND REC'D A RESULT OF 234 MG/DL. THE NORMAL RANGE WAS NOT PROVIDED, BUT SHOULD BE AROUND 105-145 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER DECLINED TO TROUBLESHOOT AND ENDED THE CALL. NO PRODUCT WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NBW BAYER HEALTHCARE LLC 9556C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK