BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6189724 · Received December 20, 2016

    Report

    Report Number
    2032227-2016-51497
    Event Type
    Death
    Date Received
    December 20, 2016
    Date of Event
    December 10, 2016
    Report Date
    December 13, 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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN A HOSPITAL, IN HOSPICE CARE. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2016. THE CAUSE OF DEATH WAS COMBINATION OF DIABETES AND CONGESTIVE HEART FAILURE. THE CALLER DID NOT KNOW THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH; IT HAD BEEN REMOVED BY THE HOSPITAL STAFF. THE CALLER WAS UNSURE HOW LONG PRIOR TO DEATH THE DEVICE HAD BEEN DISCONNECTED. THE CALLER STATED THAT THEY DO NOT HAVE POSSESSION OF THE CUSTOMER'S INSULIN PUMP. IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN A HOSPITAL, IN HOSPICE CARE. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2016. THE CAUSE OF DEATH WAS COMBINATION OF DIABETES AND CONGESTIVE HEART FAILURE. THE CALLER DID NOT KNOW THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN A HOSPITAL, IN HOSPICE CARE. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2016. THE CAUSE OF DEATH WAS COMBINATION OF DIABETES AND CONGESTIVE HEART FAILURE. THE CALLER DID NOT KNOW THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH; IT HAD BEEN REMOVED BY THE HOSPITAL STAFF. THE CALLER WAS UNSURE HOW LONG PRIOR TO DEATH THE DEVICE HAD BEEN DISCONNECTED. THE CALLER STATED THAT THEY DO NOT HAVE POSSESSION OF THE CUSTOMER'S INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841925 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death