BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 1982545 · Received January 11, 2011

    Report

    Report Number
    1826988-2010-00880
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 22, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HIS BLOOD GLUCOSE THE DAY BEFORE HE CALLED CUSTOMER SERVICE AND REC'D A READING OF 85 MG/DL USING HIS CONTOUR METER. HE RETESTED USING ANOTHER METER AND REC'D A READING OF 205 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. DURING THE CALL, THE CUSTOMER PERFORMED CONTROL TESTS AND REC'D A RESULT OF 21 MG/DL. THE NORMAL CONTROL RANGE WAS 106-147 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER'S TEST STRIPS ARE TO BE RETURNED FOR EVAL. 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 9556C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK