BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 495507 · Received November 14, 2003

    Report

    Report Number
    2183502-2003-00047
    Event Type
    Injury
    Date Received
    November 14, 2003
    Date of Event
    October 13, 2003
    Report Date
    November 13, 2003
    Manufacturer
    DELTEC, INC.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE PT WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE REPORTER COULD NOT ELABORATE AS THE NATURE OF THE ALLEGED MALFUNCTION. IT WAS REPORTED THAT THE PT'S BLOOD GLUCOSE LEVELS WERE RUNNING AROUND 150-190 IN THE EVENING, THE NEXT MORNING PT AROUND 290, PT WAS BROUGHT TO THE ER. THE REPORTER WAS UNABLE TO PROVIDE ANY INFO REGARDING BASAL RATE, PROGRAMMING, OR INSERTION SITE HISTORY OR DIFFICULTIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COZMO INSULIN PUMP INSULIN PUMP LZG DELTEC, INC. 1700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization