BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 641162 · Received October 11, 2005

    Report

    Report Number
    1826988-2005-00032
    Event Type
    Other
    Date Received
    October 11, 2005
    Date of Event
    October 3, 2005
    Report Date
    October 3, 2005
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED STATING THAT THE METER WAS REPORTING HIGH RESULTS. THEIR METER REPORTED A RESULT OF 99MG/DL, COMPARED TO THE PARAMEDICS RESULT OF 34MG/DL. AN EVALUATION OF THE SYSTEM WAS CONDUCTED OVER THE PHONE WHICH DETERMINED THAT THE METER IS WORKING WITHIN SPECIFICATIONS. CUSTOMER WILL RETURN STRIPS AND CONTROL SOLUTION FOR EVALUATION, AND REPLACEMENT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 7151 4LB3A05

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other