BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6086457 · Received November 8, 2016

    Report

    Report Number
    2032227-2016-39752
    Event Type
    Death
    Date Received
    November 8, 2016
    Date of Event
    October 6, 2016
    Report Date
    October 31, 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 CALLER STATED THAT THE CUSTOMER'S BODY WAS DECOMPOSED WHEN IT WAS FOUND. THE CALLER STATED THAT THE CAUSE OF DEATH IS UNKNOWN AT THIS TIME BECAUSE THE AUTOPSY IS STILL NOT COMPLETED. THE CALLER STATED THAT THE CUSTOMER HAD AN ANEURISM, HEMORRHAGE, AND EMPHYSEMA ON (B)(6) 2016 WHICH KEPT THE CUSTOMER IN THE INTENSIVE CARE UNIT FIR FIVE WEEKS AND IN THE REHAB FOR FOUR WEEKS. THE CUSTOMER ALSO HAD A STROKE. THE CUSTOMER HAD DIABETIC KETOACIDOSIS WHEN IN THE HOSPITAL. THE CALLER STATED THAT THE CUSTOMER WAS VERY DETAILED IN DOCUMENTING HER BLOOD GLUCOSE AND DIET AND THE LAST BLOOD GLUCOSE ENTRY IN HER DOCUMENTATIONS WAS ABOVE 500 MG/DL ON (B)(6) 2016. THE CALLER STATED THAT THE CUSTOMER WAS NON-COMPLIANT WITH THE DOCTOR ABOUT EATING RIGHT AND STAYING ON A PLAN. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER DECLINED RETURNING THE INSULIN PUMP AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736278 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death