BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE2 TEST STRIPS (100)

    MDR report key: 1032079 · Received April 18, 2008

    Report

    Report Number
    1826988-2008-00438
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 1, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 345 MG/DL USING ONE OF HIS BREEZE2 METERS. HE RETESTED USING ANOTHER BREEZE 2 AND RECEIVED A READING OF 83 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 TEST STRIPS ARE TO BE RETURNED FOR EVAL. THE CUSTOMER ALSO INSISTED THE METER BE REPLACED. REPLACEMENT PRODUCTS 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 1A5011AA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK