BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 1050352 · Received May 23, 2008

    Report

    Report Number
    2183502-2008-00132
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 18, 2008
    Report Date
    May 23, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    INFORMATION WAS RECEIVED THAT REPORTED A PATIENT WAS HOSPITALIZED IN 2008 DUE AN INCIDENT OF HYPERGLYCEMIA. THE PATIENT WAS ADMITTED DUE TO HIGH BLOOD GLUCOSE. SHE WAS TREATED WITH IV FLUIDS AND INSULIN. THE INSULIN PUMP WILL 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 COZMO INSULIN PUMP INSULIN PUMP LZG SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 1700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization