BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 1151383 · Received September 4, 2008

    Report

    Report Number
    2183502-2008-00254
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    August 4, 2008
    Report Date
    September 4, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT REPORTED A PT EXPERIENCED HYPERGLYCEMIA. ALLEGEDLY THE PT SOUGHT HOSP TREATMENT FOR HIGH BLOOD GLUCOSE. THE PATIENT WAS RELEASED AFTER TREATMENT. THE DEVICE SHOULD BE RETURNED FOR EVALUATION; TO ENSURE THAT IS FUNCTIONING CORRECTLY AND DID NOT CONTRIBUTE TO THE REPORTED INCIDENCE, BUT AT THE TIME OF THIS REPORT HAD NOT BEEN RETURNED.

    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