BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC COZMO INSULIN PUMP

    MDR report key: 1812186 · Received August 18, 2010

    Report

    Report Number
    2183502-2010-00357
    Event Type
    Injury
    Date Received
    August 18, 2010
    Date of Event
    July 19, 2010
    Report Date
    August 17, 2010
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    PMA / PMN Number
    K062323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMPLETED THE ENTIRE FORM. (B)(4). 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

    IT WAS REPORTED BY A CUSTOMER COMPLAINT THAT THE PATIENT WAS TREATED BY PARAMEDICS DUE AN INCIDENT OF LOW BLOOD GLUCOSE. THE REPORTER STATES THAT ON 07/19 HIS BLOOD GLUCOSE WAS MEASURED AT 3.8 MMOL/L, HE CALLED THE PARAMEDICS. THE PARAMEDICS ADMINISTERED GLUCOSE AND ORANGE JUICE. THE PATIENT WAS STABILIZED ON SCENE AND NOT TRANSPORTED. THE DEVICE SHOULD BE RETURNED FOR EVALUATION; TO ENSURE THAT IT IS FUNCTIONING CORRECTLY AND DID NOT CONTRIBUTE TO THE REPORTED INCIDENCE.

    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 UNK Other