BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5547468 · Received April 5, 2016

    Report

    Report Number
    3004209178-2016-97400
    Event Type
    Death
    Date Received
    April 5, 2016
    Date of Event
    March 26, 2016
    Report Date
    April 1, 2016
    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

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AT WORK; HE WAS FOUND LYING DOWN. THE CAUSE OF IS STILL PENDING. THE CALLER STATED THAT THE CUSTOMER DID NOT HAVE ANY OTHER ILLNESSES OTHER THAN TYPE 1 DIABETES, WHICH HE HAD ONLY FOR THE LAST TWO YEARS. THE CALLER DID NOT KNOW THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CALLER STATED THAT THE CUSTOMER WAS USING SENSORS, HOWEVER, THE CUSTOMER WAS UNSURE WHETHER A SENSOR WAS WORN AT THE TIME OF DEATH OR NOT. THE CALLER STATED THAT THEY DO NOT HAVE THE CUSTOMER'S INSULIN PUMP AT THE MOMENT BUT AGREED TO CALL BACK IF IT IS EVER RETRIEVED. SINCE THE CALLER DID NOT HAVE THE INSULIN PUMP AT THE TIME OF THE PHONE CALL THE DEVICE INFORMATION COULD NOT BE VERIFIED. THE INSULIN PUMP INFORMATION USED ON THIS MEDWATCH REPORT IS THE LAST KNOWN INSULIN PUMP TO HAVE BEEN ISSUED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203595 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 55 YR Death