BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE (US)

    MDR report key: 828246 · Received February 28, 2007

    Report

    Report Number
    1826988-2007-00114
    Event Type
    Malfunction
    Date Received
    February 28, 2007
    Date of Event
    February 17, 2007
    Report Date
    February 17, 2007
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE READINGS HAD BEEN HIGHER THAN USUAL. HE PERFORMED CONTROL TESTS USING 2 DIFFERENT LOTS OF TEST STRIPS WHILE TROUBLESHOOTING AND RECEIVED RESULTS OF 295, 305, AND 252 MG/DL. THE NORMAL CONTROL RANGES WERE 113-162 MG/DL AND 115-166 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE METER IS TO BE RETURNED FOR EVALUATION, AND A REPLACEMENT METER WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA BREEZE (US) BLOOD GLUCOSE METER CGA BAYER HEALTHCARE, LLC 6117 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR