BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMONITOR GLUCOSE MONITOR

    MDR report key: 1060406 · Received June 12, 2008

    Report

    Report Number
    2183502-2008-00152
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    May 13, 2008
    Report Date
    June 11, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVAL. 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 EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER COMPLAINT THAT THE PT WAS TREATED BY PARAMEDICS DUE TO AN INCIDENT OF LOW BLOOD GLUCOSE. THE REPORTER STATED THAT THE INSULIN INFUSION PUMP WITH BLOOD GLUCOSE MONITOR GAVE A RESULT WHICH WAS BETWEEN 30 TO 40 MG/DL DIFFERENT FROM THE OTHER METER FOR WHICH THEY CORRECTED. REPORTEDLY THE PT HAD A HYPOGLYCAEMIC REACTION. THE PARAMEDICS WERE SUMMONED AND HE WAS TREATED ON SCENE WITH GLUCOSE. THE DEVICE SHOULD 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 COZMONITOR GLUCOSE MONITOR GLUCOSE MONITOR NBW SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 1790 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other COZMO INSULIN PUMP 1700