BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 2122937 · Received June 9, 2011

    Report

    Report Number
    2183502-2011-00460
    Event Type
    Injury
    Date Received
    June 9, 2011
    Report Date
    June 7, 2011
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    PMA / PMN Number
    K031738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT REPORTED A PT WAS HOSPITALIZED DUE TO AN INCIDENT OF DIABETIC KETOACIDOSIS. PER THE REPORT, THE PT STRUGGLED WITH HIGH BLOOD GLUCOSE AND BOLUS VIA PUMP WERE UNSUCCESSFUL IN LOWERING HER BLOOD GLUCOSE. SHE WAS BROUGHT TO THE ER. SHE WAS ADMITTED AND TREATED WITH INSULIN AND IV FLUIDS. THE DEVICE SHOULD BE RETURNED FOR EVAL; TO ENSURE THAT IT IS FUNCTIONING CORRECTLY AND DID NOT CONTRIBUTE TO THE REPORTED INCIDENCE, BUT AT THE TIME OF THIS REPORT HAS 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