BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE2 TEST STRIPS (50)

    MDR report key: 1053394 · Received May 22, 2008

    Report

    Report Number
    1826988-2008-00528
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE TESTED HER BLOOD GLUCOSE USING HER BREEZE 2 METER AND RECEIVED A READING OF 49 MG/DL. SHE RETESTED USING ANOTHER METER AND RECEIVED A READING OF 228 MG/DL. THE DIFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS WERE 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 NOT PROVIDED AA5223AA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK