BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC COZMO INSULIN PUMP

    MDR report key: 1073646 · Received July 8, 2008

    Report

    Report Number
    2183502-2008-00180
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 6, 2008
    Report Date
    July 8, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    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 FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT REPORTED A PT WAS HOSPITALIZED FOR CARDIAC SURGERY RECOVERY EXPERIENCED AN INCIDENT OF HYPERGLYCEMIA WHILE IN THE HOSPITAL. THE REPORTER STATED THAT THE PT HAD BLOOD GLUCOSE >500 MG/DL FOR WHICH HE WAS TREATED AND HE DISCONTINUED USE OF THE DEVICE. 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, HAD 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