BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR TS TEST STRIPS (50)

    MDR report key: 1070593 · Received July 1, 2008

    Report

    Report Number
    1826988-2008-00722
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 13, 2008
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HOSPITAL BIOLOGIST IN ANOTHER COUNTRY, CONTACTED BAYER ABOUT A HIGH NEONATAL BLOOD GLUCOSE READING USING THE CONTOUR TS SYSTEM. THE CONTOUR TS GAVE A BLOOD GLUCOSE READING OF .97 G/L (97 MG/DL), WHILE A LAB TEST PERFORMED AT THE SAME TIME GAVE A READING OF .42 G/L (42 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. THE TEST STRIPS ARE TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA CONTOUR TS TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7KD3E01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK