BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 1011868 · Received March 10, 2008

    Report

    Report Number
    2183502-2008-00048
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    February 12, 2008
    Report Date
    March 7, 2008
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. THE BROKEN CARTRIDGE CAP WAS NOT RETURNED. A NEW CARTRIDGE CAP WAS ATTACHED TO THE DEVICE AND THE DEVICE WAS FOUND TO OPERATE WITHOUT ERROR. DELIVERY AND ACCURACY TESTS WERE PERFORMED, THE DEVICE WAS FOUND TO PASS ALL DELIVERY AND ACCURACY TESTS. DAMAGE TO THE CARTRIDGE CAP AS DESCRIBED BY THE REPORTER WOULD RESULT IN THE DEVICE'S INABILITY TO OPERATE PROPERLY; THE DEVICE WOULD GO INTO AN ALARM CONDITION TO ALERT THE USER OF AN ISSUE THAT THE USER MUST ACKNOWLEDGE TO SILENCE THE ALARM. THE PUMP HISTORY WAS DOWNLOADED AND ANALYZED, THEY WERE NUMEROUS (>10) ALARMS THAT THE DEVICE DISPLAYED AND THE USER ACKNOWLEDGED.

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT REPORTED A PT WAS HOSPITALIZED IN 2008 DUE TO AN INCIDENT OF DIABETIC KETOACIDOSIS. IT WAS REPORTED THAT THE PT HAD DROPPED AND DAMAGED THE PUMP ABOUT FOUR DAYS PRIOR. AT THE TIME THE DEVICE WAS DAMAGED THE USER NOTED THAT THE CARTRIDGE CAP WAS BROKEN AND WOULD NOT HOLD AN INSULIN CARTRIDGE SECURELY IN PLACE. RATHER THEN CALL HER MD FOR A BACK-UP PLAN OR THE DEVICE MANUFACTURER FOR A NEW DEVICE THE USER ATTEMPTED TO CONTINUE TO TRY TO USE THE DEVICE TO DELIVER INSULIN. ON THE DAY OF HOSPITALIZATION, THE PT WAS ADMITTED TO THE HOSP IN DKA. THE PT WAS TREATED WITH IV FLUIDS AND INSULIN. 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 1700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization