BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 672965 · Received February 2, 2006

    Report

    Report Number
    1826988-2006-00057
    Event Type
    Malfunction
    Date Received
    February 2, 2006
    Date of Event
    January 6, 2006
    Report Date
    January 6, 2006
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONTACT STATES THEY ARE GETTING ERRATIC BLOOD AND CONTROL RESULTS. CUSTOMER SVC HAD THE CALLER RUN NORMAL CONTROL TESTS. THE RESULTS WERE 243, 103, 154MG/DL. THE RANGE IS 86-116MG/DL. A NEW BOTTLE OF STRIPS (SAME LOT#) PRODUCED A 149MG/DL CONTROL RESULT. A CHECK STANDARD WAS WITHIN RANGE. THE CONTACT WAS GOING TO RETURN THE METER, STRIPS, AND CONTROL FOR EVALUATION. A LOCAL PHARMACY WAS REPLACING THE METER WITH A BREEZE METER KIT. CUSTOMER SVC WILL FOLLOW UP WITH EVALUATION RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN