BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC COZMO INSULIN PUMP

    MDR report key: 1241720 · Received November 20, 2008

    Report

    Report Number
    2183502-2008-00346
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 19, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC INC)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 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

    IT WAS REPORTED BY A CUSTOMER COMPLAINT THAT THE PATIENT WAS TREATED BY PARAMEDICS DUE AN INCIDENT OF LOW BLOOD GLUCOSE. THE REPORTER STATES THAT ON THE EVENT DATE, AT 7:30AM HER BLOOD GLUCOSE WAS MEASURED AT 34 MG/DL, SHE CALLED THE PARAMEDICS. THE PARAMEDICS ADMINISTERED GLUCOSE. THE PATIENT WAS STABILIZED ON SCENE AND NOT TRANSPORTED. THE PATIENT'S FAMILY DOCTOR BELIEVES THAT HER PUMP SETTINGS MAY NOT BE CORRECT. THE DEVICE SHOULD 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 57 YR Other