BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC COZMO INSULIN PUMP

    MDR report key: 1211762 · Received October 24, 2008

    Report

    Report Number
    2183502-2008-00309
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 23, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. DELIVERY AND ACCURACY TESTS WERE PERFORMED, THE DEVICE WAS FOUND TO PASS ALL 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 TO AN INCIDENT OF HYPERGLYCEMIA. THE PATIENT STATES HE HAD LABILE BLOOD GLUCOSE FOR SEVERAL DAYS PRIOR TO THE HOSPITALIZATION WITH FREQUENT HIGHS. ON THE SAME DAY, HE WAS HOSPITALIZED AND TREATED WITH IV FLUIDS AND INSULIN. THE DEVICE 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 DELTEC COZMO INSULIN PUMP INSULIN PUMP LZG SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 1800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization