BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1221914 · Received November 4, 2008

    Report

    Report Number
    1826988-2008-01321
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 15, 2008
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HIS CONTOUR METER WAS READING TOO HIGH. HE TESTED HIS GLUCOSE USING HIS CONTOUR METER AND RECEIVED READINGS AROUND 190-194 MG/DL. HE RETESTED USING ANOTHER METER AND RECEIVED READINGS AROUND 98-110 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. ON ANOTHER OCCASION THE CUSTOMER TESTED HIS GLUCOSE AND RECEIVED A READING AROUND 165 MG/DL. A FEW MINUTES AFTER TESTING, HE PASSED OUT. WHEN HE AWOKE, HE WAS GIVEN JUICE TO RAISE HIS BLOOD GLUCOSE. THE CUSTOMER'S TEST STRIPS ARE TO BE RETURNED FOR EVAL. REPLACEMENT 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 7097B 7LC3D11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention