BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5066112 · Received September 9, 2015

    Report

    Report Number
    2032227-2015-42562
    Event Type
    Death
    Date Received
    September 9, 2015
    Date of Event
    September 4, 2015
    Report Date
    February 7, 2017
    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. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, AND EXCESSIVE NO DELIVERY ALARM TESTS. THE INSULIN PUMP HAD A SMALL CRACK ON THE DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE AND CRACKED RESERVOIR TUBE LIP. THE DAILY TOTAL OF INSULIN WAS 17.475 UNITS ON (B)(6) 2015, 20.850 UNITS ON (B)(6) 2015, 16.475 UNITS ON (B)(6) 2015, 12.075 UNITS ON (B)(6)2015, 22.075 UNITS ON (B)(6) 2015, 27.175 UNITS ON (B)(6) 2015, AND 25.125 UNITS ON (B)(6)2015.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED BY FAILURE ANALYSIS THAT WAS NOT INCLUDED ON THE INITIAL DEVICE EVALUATION: THE INSULIN PUMP PASSED THE DISPLACEMENT ACCURACY TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AT HOME. THE CAUSE OF DEATH IS UNKNOWN. THE CALLER STATED THAT IT COULD BE DUE TO A SEIZURE. THE CALLER STATED THAT THE CUSTOMER HAD VASCULAR DEMENTIA, LOW BLOOD GLUCOSE OF 41 MG/DL WHEN SEIZING. A FEW DAYS PRIOR TO PASSING, THE CUSTOMER HAD ANOTHER SMALL SEIZURE BUT HAD NORMAL BLOOD GLUCOSE. THE ISSUE HAD STARTED FOUR YEARS AGO. THE CUSTOMER HAD A KIDNEY TRANSPLANT AT THE AGE OF TWENTY-NINE AND HAD FIVE STENTS A FEW YEARS AGO. THE CUSTOMER'S BLOOD GLUCOSE, AT THE TIME OF DEATH, WAS 41 MG/DL; RECORDED ON (B)(6) 2015 AT 11:16 PM. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF PASSING. THE CUSTOMER WAS NOT USING SENSORS AND WAS NOT WEARING ONE AT THE TIME OF DEATH. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594418 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 56 YR Death