BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE2 TEST STRIPS (30)

    MDR report key: 1030585 · Received April 15, 2008

    Report

    Report Number
    1826988-2008-00380
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 19, 2008
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE TESTED HER BLOOD GLUCOSE USING HER BREEZE2 METER AND RECEIVED A READING OF 504 MG/DL. SHE RETESTED USING ANOTHER METER AND RECEIVED A READING OF 92 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "D" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER'S 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 ASCENSIA BREEZE2 TEST STRIPS (30) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 9674 1A5043AA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK