BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 1113163 · Received August 12, 2008

    Report

    Report Number
    2183502-2008-00221
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 15, 2008
    Report Date
    August 12, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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, NO ANOMALIES WERE FOUND. NO OPERATIONAL OR FUNCTIONAL FAILURE WAS DETECTED AND THE PRODUCT WAS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT REPORTED A PT WAS HOSPITALIZED IN 2008, DUE TO AN INCIDENT OF DIABETIC KETOACIDOSIS. THE PT STATED HIS BLOOD GLUCOSE PRIOR TO THE HOSPITALIZATION WAS "HIGH". UPON ADMISSION, THE PT'S BLOOD GLUCOSE WAS 497 MG/DL. THE PT WAS DIAGNOSED WITH DKA 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