BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE2 TEST STRIPS (100)

    MDR report key: 1031885 · Received April 15, 2008

    Report

    Report Number
    1826988-2008-00384
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 20, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS TESTED USING 2 BREEZE METERS. THE FIRST METER READ 379 MG/DL, WHILE THE SECOND METER READ 149MG/DL. THE DIFFERENCE 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 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 (100) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 1466 1T5209AA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK