BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 1081309 · Received July 22, 2008

    Report

    Report Number
    2183502-2008-00203
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 22, 2008
    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

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE, AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT REPORTED A PT WAS HOSPITALIZED IN 2008 DUE TO AN INCIDENT OF DIABETIC KETOACIDOSIS. THE PT STATED SHE WAS HAVING ISSUES WHERE SOON AFTER SET AND CARTRIDGE CHANGES HER BLOOD GLUCOSE WILL GO HIGH FOR 24 HOURS BEFORE COMING DOWN. SHE STATES SHE WAS RECENTLY HOSPITALIZED FOR HYPERGLYCEMIA. SHE WAS TREATED WITH IV INSULIN AND RELEASED. THE PT DESCRIBES THAT SHE TYPICALLY CHANGES HER SITE AND SET EVERY SIC DAYS AND HER INSULIN CARTRIDGE AFTER EVERY OTHER SITE AND SET CHANGE. THE DEVICE SHOULD BE RETURNED FOR EVALUATION; TO ENSURE THAT IT IS FUNCTIONING CORRECTLY AND DID NOT CONTRIBUTE TO THE REPORTED INCIDENCE, BUT AS OF THE DATE OF THIS REPORT, DEVICE HAD NOT BEEN 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 UNK Hospitalization