BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 1113149 · Received August 12, 2008

    Report

    Report Number
    2183502-2008-00217
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 12, 2008
    Report Date
    August 11, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE DEVICE IS CURRENTLY BEING EVALUATED; THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT REPORTED A PT WAS HOSPITALIZED IN 2008 DUE TO AN INCIDENT OF DIABETIC KETOACIDOSIS. THE PT REPORTED THAT SHE WAS SICK AND THROWING UP ON THE SAME DAY FROM 5:00 AM TO 4:00 PM. THE PT REPORTED THAT HER BLOOD GLUCOSE PRIOR TO THE HOSPITALIZATION WAS >400 MG/DL. UPON ADMISSION, THE PT'S BLOOD GLUCOSE WAS 319 MG/DL. THE PT WAS DIAGNOSED WITH DKA AND DEHYDRATION. THE DEVICE WILL BE RETURNED FOR EVAL; 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 COZMO INSULIN PUMP INSULIN PUMP LZG SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 1700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization