BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 1011869 · Received March 10, 2008

    Report

    Report Number
    2183502-2008-00037
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    February 11, 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
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. DELIVERY, OCCLUSION AND ACCURACY TESTS WERE PERFORMED, THE DEVICE WAS FOUND TO PASS ALL DELIVERY, OCCLUSION 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 SPEC.

    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 BEGAN FEELING ILL AROUND 10:00AM ON THE SAME DAN, AND SHE HAD BLOOD GLUCOSE OF >300MG/DL. THE PT WENT TO THE ER AND HAD BLOOD GLUCOSE OF 305MG/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 Hospitalization