BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1212755 · Received October 20, 2008

    Report

    Report Number
    1826988-2008-01206
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THAT SHE TESTED THE CUSTOMER'S BLOOD GLUCOSE AND RECEIVED A READING OF "HI" USING THE CUSTOMER'S METER. SHE RETESTED THE CUSTOMER USING HER OWN CONTOUR METER AND RECEIVED A READING OF 171 MG/DL. THE CUSTOMER'S METER READING WAS OFF THE CHART, BUT THE DIFFERENCE BETWEEN THE READINGS APPEARS TO FALL IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. THE ADVOCATE ALSO PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 267 MG/DL. THE NORMAL CONTROL RANGE WAS 104-144 MG/DL. 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 CONTOUR TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 7097B 7EC3D01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK