BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE2 TEST STRIPS (100)

    MDR report key: 1060959 · Received June 13, 2008

    Report

    Report Number
    1826988-2008-00620
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 15, 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 HE TESTED HIS BLOOD GLUCOSE AND RECEIVED A READING OF 423 MG/DL. HIS GLUCOSE WAS RETESTED USING 2 OTHER METERS AND THOSE READING WERE IN THE 100'S (MG/DL). THE DIFFERENCES BETWEEN THE CUSTOMER'S READINGS FALLS IN THE "C" OR "D" ZONES OF THE PARKES ERROR DEPENDING ON THE OTHER READINGS. THIS MAKES THE DIFFERENCES 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 1467 1A5238AA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK