BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 1200662 · Received October 17, 2008

    Report

    Report Number
    2183502-2008-00305
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 20, 2008
    Report Date
    October 17, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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; ON THE DAY OF THE EVENT, THE PUMP WENT INTO AN ALARM CONDITION THAT REQUIRED USER INTERVENTION 8 SEPARATE TIMES. THE ORIGINAL INSULIN CARTRIDGE AND INFUSION SET WERE NOT RETURNED ALONG WITH THE PUMP.

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT REPORTED A PT WAS HOSPITALIZED IN 2008, DUE TO HYPERGLYCEMIA. THE PT REPORTS HER DEVICE BEGAN ALARMING AROUND 08:00 AM ON THE SAME DAY. THIS ALARM WOULD PERSIST UNTIL THE PT WOULD REMOVE AND REINSTALL A BATTERY. THIS CONTINUED THROUGHOUT THE MORNING UNTIL THE PUMP ALARMED CONTINUALLY AND WOULD NOT FUNCTION AFTER BATTERY REINSTALLATION. THE PT PRESENTED TO THE ER SYMPTOMATIC OF HYPERGLYCEMIA AROUND 02:30 PM. UPON ADMIT, THE PT'S BLOOD GLUCOSE WAS >500MG/DL AND SHE WAS TREATED WITH INSULIN AND IV FLUIDS. THE DEVICE SHOULD BE RETURNED FOR EVALUATION

    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