BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC COZMO INSULIN PUMP

    MDR report key: 2091466 · Received May 6, 2011

    Report

    Report Number
    2183502-2011-00388
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    March 31, 2011
    Report Date
    May 3, 2011
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    PMA / PMN Number
    K062323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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 ON (B)(6) 2011, DUE INCIDENCE OF HYPERGLYCEMIA. PER THE PT, HE CHANGED HIS INSULIN CARTRIDGE, SITE, AND INFUSION SET AT 5:00PM ON (B)(6) 2011. PRIOR TO RETIRING FOR THE EVENING, HE CHECKED HIS BLOOD GLUCOSE AND IT WAS >400 MG/DL. THE NEXT MORNING, HE AWOKE FEELING ILL BUT DID NOT CHECK HIS BLOOD GLUCOSE. AT NOON, HE WAS STILL ILL AND HE CHECKED HIS BLOOD GLUCOSE, AT HIS TIME IT WAS >600 MG/DL. HE WENT TO THE HOSPITAL AND 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 DELTEC COZMO INSULIN PUMP INSULIN PUMP LZG SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 1800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention