BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 1001941 · Received February 20, 2008

    Report

    Report Number
    2183502-2008-00022
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 22, 2008
    Report Date
    February 19, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. FUNCTIONAL, DELIVERY AND ACCURACY TESTS WERE PERFORMED, THE DEVICE WAS FOUND TO PASS ALL FUNCTIONAL, DELIVERY AND ACCURACY TESTS. NO OPERATIONAL OR FUNCTIONAL FAILURE WAS DETECTED AND THE PRODUCT WAS WITHIN SPEC.

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT REPORTED A PT WAS HOSPITALIZED IN 2008, DUE TO DIABETIC KETOACIDOSIS. IT WAS REPORTED THAT THE PT HAD BEEN DEALING WITH HIGH BLOOD SUGARS FOR A WEEK PRIOR TO THE HOSPITALIZATION. THE PT BEGAN VOMITING ONE DAY PRIOR, AROUND NOON. THE PT CONTINUED TO BE SICK AND THE FOLLOWING DAY, AT 8:00 PM HE WAS ADMITTED TO THE HOSP WITH A BLOOD GLUCOSE OF >400. 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.

    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