BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 948989 · Received November 13, 2007

    Report

    Report Number
    2183502-2007-00341
    Event Type
    Injury
    Date Received
    November 13, 2007
    Date of Event
    October 12, 2007
    Report Date
    November 12, 2007
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: 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 SPECIFICATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT REPORTED A PATIENT WAS TREATED BY PARAMEDICS ON 10/12/2007 DUE TO AN INCIDENT OF HYPOGLYCEMIA. THE REPORTER STATES THE PATIENT HAD AN INCIDENT OF LOW BLOOD GLUCOSE WHILE PLAYING ON THE PLAYGROUND AND BECAME UNCONSCIOUS. THE PARAMEDICS WERE SUMMONED AND ROUSED THE PATIENT WITH GLUCOSE. THE REPORTER STATES THE PATIENT IS MEDICALLY COMPLEX WITH ASTHMA AND GASTROPORESIS. THE DEVICE SHOULD 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 YR Other