BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE2

    MDR report key: 1071518 · Received July 3, 2008

    Report

    Report Number
    1826988-2008-00765
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 11, 2008
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT HE PERFORMED CONTROL TESTS AND RECEIVED RESULTS OF 277 AND 280 MG/DL. THE NORMAL CONTROL RANGE WAS 94-129 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVAL. BUT HE DECLINED. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA BREEZE2 BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC 1440 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK