BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1201849 · Received October 15, 2008

    Report

    Report Number
    1826988-2008-01156
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 25, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE HAD PASSED OUT DUE TO LOW BLOOD GLUCOSE. HER SON GAVE HER GLUCODEN IN ORDER TO RAISE HER BLOOD GLUCOSE. THE CUSTOMER TESTED HER GLUCOSE ONCE SHE WOKE UP AND RECEIVED A READING OF 410 MG/DL USING HER CONTOUR METER. SHE RETESTED USING ANOTHER METER AND RECEIVED A READING AROUND 100 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "D" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. THE CUSTOMER'S TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. A NEW CONTOUR KIT AND REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 7080D 7HC3D03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention