BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC COZMO INSULIN PUMP

    MDR report key: 1063381 · Received June 19, 2008

    Report

    Report Number
    2183502-2008-00158
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 19, 2008
    Report Date
    June 18, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    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 REC'D THAT REPORTED A PT WAS HOSPITALIZED IN 2008, DUE TO AN INCIDENT OF HYPERGLYCEMIA. THE PT WORKS THE THIRD SHIFT, AT WORK SHE BEGAN FEELING DEHYDRATED AND TIRED. SHE TESTED HER BLOOD GLUCOSE AND IT WAS EXCESS OF 600 MG/DL. SHE WAS BROUGHT TO THE HOSP WHERE UPON ADMIT HER BLOOD GLUCOSE WAS 700MG/DL. SHE WAS TREATED WITH IV FLUIDS, AND INSULIN. THE DEVICE SHOULD BE RETURNED FOR EVAL; 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 EVAL.

    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