BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE TEST STRIPS (50)

    MDR report key: 1212756 · Received October 20, 2008

    Report

    Report Number
    1826988-2008-01205
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 3, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HER BLOOD GLUCOSE USING HER ELITE METER AND RECEIVED A READING OF 214 MG/DL. SHE RETESTED USING ANOTHER METER AND RECEIVED A READING OF 93 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 EVAL. A NEW CONTOUR METER KIT WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 3918A 8C05AS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK