BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 1163627 · Received September 9, 2008

    Report

    Report Number
    2183502-2008-00257
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 11, 2008
    Report Date
    September 8, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE, AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THE PATIENT WAS HOSPITALIZED FOR INCIDENCE OF HYPERGLYCEMIA. THE PATIENT REPORTS SHE HAD LABILE BLOOD GLUCOSE LEVELS. SHE WAS HOSPITALIZED WITH DIABETIC KETOACIDOSIS AND TREATED WITH IV FLUIDS AND INSULIN. THE DEVICE SHOULD BE RETURNED FOR EVALUATION; 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 EVALUATION.

    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 UNK Hospitalization