BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1024264 · Received March 27, 2008

    Report

    Report Number
    1826988-2008-00315
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    February 29, 2008
    Report Date
    February 29, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP INFORMATION WAS NOT PROVIDED, BECAUSE THE LOT NUMBER PROVIDED BY THE CUSTOMER WAS NOT CORRECT.

    Description of Event or Problem · 1

    THE CUSTOMER PERFORMED COMPARISON BLOOD GLUCOSE TESTS USING HIS 2 CONTOUR METERS. THE OLDER OF THE TWO METERS READ 190 MG/DL, WHILE THE NEWER METER READ 92 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 AND METER ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT PRODUCTS WERE SENT TO THE CUSTOMER.

    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 UNK