BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 1011877 · Received March 10, 2008

    Report

    Report Number
    2183502-2008-00036
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    February 9, 2008
    Report Date
    March 6, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: 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

    INFO WAS RECEIVED THAT REPORTED A PT WAS HOSPITALIZED IN 2008, DUE AN INCIDENT OF HYPERGLYCEMIA. IT WAS REPORTED THAT THE PT HAD BEEN ILL WITH A SINUS INFECTION FOR ABOUT 6 WEEKS. THE EVENING BEFORE THE INCIDENT THE PT WAS FEELING PARTICULARLY SICK AND DID NOT EAT DINNER, NOR DID SHE EAT BREAKFAST THE NEXT DAY. MIDMORNING THE PT BEGAN VOMITING AND SPILLING KETONES. THE PT WAS BROUGHT TO THE HOSP AND HAD BLOOD GLUCOSE OF >700MG/DL UPON ADMISSION. THE PT WAS TREATED WITH IV FLUIDS AND INSULIN. THE DEVICE SHOULD 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 14 YR Hospitalization