BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC COZMO INSULIN PUMP

    MDR report key: 1011866 · Received March 10, 2008

    Report

    Report Number
    2183502-2008-00047
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    February 2, 2008
    Report Date
    March 7, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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 INCIDENCE OF DIABETIC KETOACIDOSIS. THE RPTR STATED THAT HER DAUGHTER WOKE UP VOMITING AND SHORT OF BREATH. THE RPTR STATES THAT THE PT'S LAST BLOOD GLUCOSE READING BEFORE THE HOSPITALIZATION WAS ON >500MG/DL. THE PT WAS BROUGHT TO THE ER AND WAS ADMITTED WITH A BLOOD GLUCOSE OF 596 MG/DL. THE PT 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 HAS 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