BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TS

    MDR report key: 2874513 · Received December 14, 2012

    Report

    Report Number
    1826988-2012-00657
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 28, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HER BLOOD GLUCOSE USING HER CONTOUR TS METER AND RECEIVED READINGS OF 215 AND 223 MG/DL. SHE RETESTED USING ANOTHER METER AND RECEIVED A READING OF 118MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. 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 TS BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 1820 2ED3E04

    Patients

    Seq Age Sex Outcome Treatment
    1