BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2142673 · Received June 21, 2011

    Report

    Report Number
    1826988-2011-00335
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HER CONTOUR METER. SHE PERFORMED A CONTROL TEST DURING THE CALL AND RECEIVED A RESULT OF 292 MG/DL. THE NORMAL CONTROL RANGE WAS 108 - 149 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS WERE TO BE RETURNED FOR EVAL, BUT THEY WERE NOT RECEIVED BY THE QA LAB. REPLACEMENT TEST STRIPS AND A NEW METER WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NBW BAYER HEALTHCARE, LLC 9545C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK