BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASCENSIA BREEZE

    MDR report key: 617899 · Received June 3, 2005

    Report

    Report Number
    1810909-2005-00146
    Event Type
    Other
    Date Received
    June 3, 2005
    Date of Event
    April 28, 2005
    Report Date
    April 28, 2005
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    CGA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED STTING THAT METER WAS REPORTING ERRATIC RESULTS. AN EVALUATION OF THE SYSTEM WAS CONDUCTED OVER THE PHONE WHICH DETRMINED THAT THE METER WAS PERFORMING WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA BREEZE BLOOD GLUCOSE METER' CGA BAYER HEALTHCARE, LLC 6117 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN