BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1032263 · Received April 18, 2008

    Report

    Report Number
    1826988-2008-00460
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 8, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THAT THE CUSTOMER TESTED HER BLOOD GLUCOSE AND RECEIVED A READING OF 300MG/DL USING HER CONTOUR METER. SHE RETESTED USING ANOTHER METER AND RECEIVED A READING OF 113 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. TROUBLESHOOTING SHOWED THE CONTOUR SYSTEM TO BE OPERATING AS DESIGNED. NO PRODUCT WILL BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK