BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 1020620 · Received March 28, 2008

    Report

    Report Number
    2183502-2008-00063
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 26, 2008
    Manufacturer
    SMITHS MEDICAL MD, FORMERLY DELTEC INC.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: 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 INCIDENCE OF HYPERGLYCEMIA. THE USER CHANGED HIS SET, SITE, AND CARTRIDGE ONE DAY PRIOR. THE NEXT DAY, THE PT AWOKE WITH A BLOOD GLUCOSE OF >400MG/DL. HE WAS ADMITTED TO THE HOSPITAL WITH A BLOOD GLUCOSE OF >600MG/DL. THE PT WAS TREATED WITH IV FLUIDS AND INSULIN. 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 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 Hospitalization