BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE2 TEST STRIPS (50)

    MDR report key: 1163658 · Received September 9, 2008

    Report

    Report Number
    1826988-2008-01006
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HIS BLOOD GLUCOSE USING HIS BREEZE2 METER AND RECEIVED A READING OF 216 MG/DL. HE RETESTED USING ANOTHER METER AND RECEIVED A READING OF 98 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. WHILE TROUBLESHOOTING, THE CUSTOMER PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 170 MG/DL. THE NORMAL CONTROL RANGE WAS 90-123 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA BREEZE2 TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 1468 1T5230AA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK