BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC COZMO INSULIN PUMP

    MDR report key: 1101165 · Received August 5, 2008

    Report

    Report Number
    2183502-2008-00212
    Event Type
    Injury
    Date Received
    August 5, 2008
    Date of Event
    July 1, 2008
    Report Date
    August 4, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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

    INFORMATION WAS RECEIVED THAT REPORTED A PATIENT WAS HOSPITALIZED IN 2008, DUE TO AN INCIDENT OF HYPERGLYCEMIA. THE PATIENT BEGAN EXPERIENCING DIFFICULTY ONE MONTH PRIOR. THE EVENING OF THE DAY, HER BLOOD GLUCOSE BECAME INCREASINGLY ELEVATED AND SHE WAS BROUGHT TO THE HOSPITAL. THE PATIENT WAS TREATED WITH IV INSULIN AND FLUIDS. THE DEVICE SHOULD BE RETUNED 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 DELTEC COZMO INSULIN PUMP INSULIN PUMP LZG SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 1800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization