BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4870020 · Received June 25, 2015

    Report

    Report Number
    3004209178-2015-69572
    Event Type
    Death
    Date Received
    June 25, 2015
    Date of Event
    June 23, 2015
    Report Date
    February 13, 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.

    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.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AT HOME, IN BED. THE CALLER STATED THAT AT NIGHT, BEFORE GOING TO SLEEP, THE CUSTOMER CHECKED HER BLOOD GLUCOSE AND GAVE HERSELF A BOLUS BECAUSE IT WAS 212 MG/DL. APPROXIMATELY, ONE AND A HALF HOURS LATER THE SPOUSE WAS AWAKENED BY THE CUSTOMER, ASKING FOR HELP. WHILE THE SPOUSE WENT OUT OF THE ROOM AND CAME BACK, THE CUSTOMER'S TONGUE WAS OUT; HER BLOOD GLUCOSE WAS 37 MG/DL. PARAMEDICS WERE CALLED, CPR AND OXYGEN WERE GIVEN, TO NO AVAIL. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER UPLOADED TO CARELINK. THE BOLUS HISTORY SHOWED THAT ON (B)(6) 2015 AT 10:42 PM THE CUSTOMER'S BLOOD GLUCOSE WAS 227 MG/DL, NORMAL DELIVERY 18.00 UNITS, ESTIMATED TOTAL 56.4 UNITS, FOOD INTAKE 300 GRAMS, FOOD BOLUS 54.50 UNITS, CORRECTION BOLUS 1.90 UNITS, ACTIVE INSULIN 0.0 UNITS. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411943 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death