BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 1001924 · Received February 21, 2008

    Report

    Report Number
    2183502-2008-00023
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 24, 2008
    Report Date
    February 20, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    INFO WAS REC'D THAT REPORTED A PT WAS HOSPITALIZED IN 2008, AT 2:00 AM DUE TO AN INCIDENT OF HYPERGLYCEMIA. THE RPTR STATED THAT THE PT BEGAN TO FEEL SICK ONE DAY PRIOR. HE WENT TO THE HOSP THE NEXT DAY, WHEN HE COULD NOT LOWER HIS BLOOD GLUCOSE. UPON ADMIT HIS BG'S WERE >500. THE PT WAS TREATED WITH IV FLUIDS AND INSULIN. THE DEVICE SHOULD BE RETURNED FOR EVAL; TO ENSURE THAT IT IS FUNCTIONING CORRECTLY AND DID NOT CONTRIBUTE TO THE REPORTED INCIDENCE, BUT AS OF THE DATE OF THIS REPORT HAD NOT BEEN RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COZMO INSULIN PUMP INSULIN PUMP LZG SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 1700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization