BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE TEST STRIPS (100)

    MDR report key: 1052393 · Received May 23, 2008

    Report

    Report Number
    1826988-2008-00541
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 25, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE TESTED HER BLOOD GLUCOSE AND REC'D A READING OF 400 MG/DL USING HER ELITE METER. SHE RETESTED USING HER CONTOUR METER AND REC'D A READING OF 160 MG/DL. THE DIFFERENCE BETWEEN 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. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE TEST STRIPS (100) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 3942A 7H05MS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK