BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC COZMO INSULIN PUMP

    MDR report key: 1831929 · Received September 7, 2010

    Report

    Report Number
    2183502-2010-00380
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    PMA / PMN Number
    K062323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT REPORTED A PATIENT WAS HOSPITALIZED ON (B)(6) 2010 DUE AN INCIDENT OF DIABETIC KETOACIDOSIS. THE PATIENT PERFORMED A SITE AND SET CHANGE ON (B)(6) 2010. THE PATIENT WOKE UP ON (B)(6) AT 9:00 AM WITH A BLOOD GLUCOSE 200 MG/DL. THE PATIENT WENT TO WORK BUT BECAME ILL AND WAS BROUGHT TO THE HOSPITAL AT 3:00PM WITH HIGH BG'S, LARGE KETONES AND VOMITING. UPON ADMIT, HIS BLOOD GLUCOSE WAS 500MG/DL. HE WAS TREATED WITH IV FLUIDS AND INSULIN. THE DEVICE SHOULD BE RETURNED FOR EVALUATION; TO ENSURE THAT IT IS FUNCTIONING CORRECTLY AND DID NOT CONTRIBUTE TO THE REPORTED INCIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTEC COZMO INSULIN PUMP INSULIN PUMP LZG SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 1800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention