BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4822552 · Received June 5, 2015

    Report

    Report Number
    3004209178-2015-63714
    Event Type
    Death
    Date Received
    June 5, 2015
    Date of Event
    May 24, 2015
    Report Date
    June 4, 2015
    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

    THE CUSTOMER'S FATHER REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY ON (B)(6) 2015 AT HOME. THE OFFICIAL CAUSE OF DEATH WAS UNDETERMINED. THE CALLER REPORTED THE CUSTOMER BECAME ILL ONE WEEK PRIOR TO THEIR PASSING. IT WAS REPORTED THE CUSTOMER COLLAPSED AT HOME AND COULD NOT BE REVIVED BY THE MEDICS. THE CUSTOMER'S EXACT BLOOD GLUCOSE AT THE TIME OF DEATH WAS UNKNOWN, BUT THE CALLER REPORTED IT WAS OVER 360 MG/DL. IT WAS ALSO UNKNOWN IF THE CUSTOMER HAD ANY OTHER COMPLICATIONS PRIOR TO THEIR PASSING. THE CALLER WAS UNSURE IF THE CUSTOMER USED SENSORS OR IF THE CUSTOMER WAS WEARING ONE AT THE TIME OF DEATH. THE CALLER STATED THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THEIR PASSING. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365980 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Death