BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 1140225 · Received August 29, 2008

    Report

    Report Number
    2183502-2008-00247
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 28, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC.)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. OCCLUSION, DELIVERY AND ACCURACY TESTS WERE PERFORMED, THE DEVICE WAS FOUND TO PASS ALL OCCLUSION, DELIVERY AND ACCURACY TESTS. THE PUMP HISTORY WAS DOWNLOADED AND ANALYZED; ON THE DAY OF THE EVENT, THE PUMP ALARMED AND THE USER ACKNOWLEDGED GREATER THAN 15 HIGH PRESSURE ALARMS. ADDITIONALLY, THE USER HAD BEEN ACKNOWLEDGING AND SILENCING APPROXIMATELY 12 HIGH PRESSURE ALARMS A DAY FOR THE WEEK PRIOR TO THE INCIDENT. NO OPERATIONAL OR FUNCTIONAL FAILURE WAS DETECTED AND THE PRODUCT WAS WITHIN SPEC. THE USER DID NOT RETURN ANY OF THE MINIMED QUICKSET ADMINISTRATION SETS HE HAD BEEN USING AT THE TIME OF THE BLOCKAGES.

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT REPORTED A PT WAS HOSPITALIZED IN '08 DUE TO AN INCIDENT OF HYPERGLYCEMIA. THE PT REPORTS HE HAD HIGH BLOOD GLUCOSE FOR A WEEK RUNNING UP TO THE HOSPITALIZATION. THE PT REPORTS THAT IN THE SAME TIME PERIOD HIS PUMP HAS BEEN ALARMING CONTINUOUS HIGH PRESSURE ALARMS. UPON ADMIT THE PT WAS DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH INSULIN AND IV FLUIDS. THE INSULIN PUMP WILL 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 Hospitalization