BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASCENSIA BREEZE

    MDR report key: 604064 · Received May 17, 2005

    Report

    Report Number
    1810909-2005-00111
    Event Type
    Other
    Date Received
    May 17, 2005
    Date of Event
    April 27, 2005
    Report Date
    April 27, 2005
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED STATING THAT THEIR METER IS REPORTING HIGH RESULTS. METER REPORTED A RESULT OF 234 MG/DL, COMPARED TO ANOTHER UNK METER'S RESULTS OF 122 MG/DL. CUSTOMER ASKED TO RETURN METER FOR FURTHER EVALUATION, AND A REPLACEMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA BREEZE BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 6177 *

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR