BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3192827 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-95123
    Event Type
    Death
    Date Received
    June 27, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER'S SPOUSE CALLED TO REPORT CUSTOMER'S DEATH. CAUSE OF DEATH, COMPLICATIONS OF DIABETES MELLITUS. CUSTOMER WAS FOUND IN CAR WITH METER STRIPS AND GLUCOSE TABLETS, MAY HAVE HAD A LOW BLOOD GLUCOSE. CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293983 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death