BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6034760 · Received October 17, 2016

    Report

    Report Number
    2032227-2016-20087
    Event Type
    Death
    Date Received
    October 17, 2016
    Date of Event
    October 6, 2016
    Report Date
    November 18, 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) SITE, PER VARIANCE 5.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RETURNED WITHOUT A BATTERY INSTALLED WHEN RECEIVED. THE INSULIN PUMP PASSED THE FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST AND EXCESSIVE NO DELIVERY TEST. THE INSULIN PUMP WAS RECEIVED WITH DEBRIS UNDER THE DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE WINDOW AND CRACKED RESERVOIR TUBE LIP. DATA ANALYSIS: (B)(6) 2016 DAILY INSULIN TOTAL = 23.250U; (B)(6) 2016 DAILY INSULIN TOTAL = 23.150U; (B)(6) 2016 DAILY INSULIN TOTAL = 21.950U; (B)(6) 2016 DAILY INSULIN TOTAL = 21.200U; (B)(6) 2016 DAILY INSULIN TOTAL = 21.375U; (B)(6) 2016 DAILY INSULIN TOTAL = 21.300U; (B)(6) 2016 DAILY INSULIN TOTAL = 11.500U. BASAL DELIVERY ONLY.

    Additional Manufacturer Narrative · 1

    THE PUMP PASSED THE DELIVERY VOLUME ACCURACY TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AT HOME. THE CAUSE OF DEATH IS STILL UNKNOWN. THE CALLER STATED THAT THE CUSTOMER'S LAST RECORDED BLOOD GLUCOSE VALUE WAS 599 MG/DL ON (B)(6) 2016 AT 2:54AM. THE CALLER STATED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CALLER WAS UNSURE WHETHER THE CUSTOMER USED SENSORS OR NOT. THE CALLER STATED THAT THEY WOULD LIKE TO KEEP THE INSULIN PUMP UNTIL THE CAUSE OF DEATH HAS BEEN DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686363 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death