BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSIA BREEZE

    MDR report key: 649132 · Received December 1, 2005

    Report

    Report Number
    1826988-2005-00080
    Event Type
    Injury
    Date Received
    December 1, 2005
    Date of Event
    November 13, 2005
    Report Date
    November 14, 2005
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    CGA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER WENT INTO HYPOGLYCEMIA AND THE SPOUSE CALLED THE PARAMEDICS. THEY TESTED HIS GLUCOSE AND GOT A RESULT OF 10 MG/DL WHILE THE BREEZE METER READ 65 MG/DL. AFTER RECOVERY, THE BREEZE METER READ LOWER THAN ANOTHER METER: BREEZE 225 MG/DL, OTHER METER 336 MG/DL. WHILE TROUBLESHOOTING ON THE PHONE, THE CUSTOMER GOT A CONTROL READING OUT OF RANGE TOO HIGH: 166 MG/DL, WITH AN EXPECTED RANGE OF 113 - 163 MG/DL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR