BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6213367 · Received December 29, 2016

    Report

    Report Number
    2032227-2016-55726
    Event Type
    Death
    Date Received
    December 29, 2016
    Date of Event
    December 15, 2016
    Report Date
    December 27, 2016
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AT HOME. THE CAUSE OF DEATH IS UNKNOWN. 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 CUSTOMER WAS NOT USING SENSORS. THE CALLER STATED THAT THE CUSTOMER HAD KIDNEY FAILURE AND HAD BEEN TREATING WITH DIALYSIS. THE CUSTOMER HAD SUFFERED FROM MINI STROKES IN THE PAST. LEADING UP TO THE CUSTOMER'S DEATH, THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE EVENT FROM WHICH HE DID NOT WAKE UP. THE CALLER AGREED TO RETURN THE INSULIN PUMP, BUT HAD NOT YET DONE SO SINCE THERE WAS NOT A WORKING BATTERY IN THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864218 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death