BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 1224876 · Received November 6, 2008

    Report

    Report Number
    2183502-2008-00326
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    October 1, 2008
    Report Date
    November 3, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    INFORMATION WAS RECEIVED THAT REPORTED A PATIENT WAS HOSPITALIZED ON 10/01/2008 DUE TO HYPERGLYCEMIA. THE REPORTER STATES THE PATIENT HAD LABILE BLOOD GLUCOSE FOR SEVERAL DAYS PRIOR TO THE HOSPITALIZATION. THE PATIENT WAS HOSPITALIZED WITH SYMPTOMS OF HIGH BLOOD GLUCOSE; SHE WAS TREATED WITH INSULIN AND IV FLUIDS, 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 (FORERLY DELTEC, INC) 1700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization