BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC COZMO INSULIN PUMP

    MDR report key: 1132101 · Received August 21, 2008

    Report

    Report Number
    2183502-2008-00234
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 22, 2008
    Report Date
    August 14, 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 EVALUATION ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    INFORMATION WAS REC'D THAT REPORTED A PT WAS HOSPITALIZED IN 2008, DUE TO AN INCIDENT OF HYPERGLYCEMIA. THE REPORTER STATED THE PT HAD TO BE HOSPITALIZED WHEN HIS BLOOD GLUCOSE BECAME >400 MG/DL. HE WAS TREATED WITH INSULIN AND FLUIDS. THE DEVICE WILL 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 Hospitalization