BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5226495 · Received November 16, 2015

    Report

    Report Number
    2032227-2015-66096
    Event Type
    Death
    Date Received
    November 16, 2015
    Date of Event
    October 25, 2015
    Report Date
    November 10, 2015
    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. 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 PASSED THE FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST AND EXCESSIVE NO DELIVERY TEST. THE INSULIN PUMP HAD CRACKED CASE AT DISPLAY WINDOW CORNER AND CRACKED RESERVOIR TUBE LIP. THE INSULIN PUMP WAS RECEIVED WITH DEPLETED BATTERY INSTALLED. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE OF 545 MG/DL, WHICH WAS TREATED WITH 14 UNITS IF INSULIN THROUGH THE INSULIN PUMP. THE CALLER STATED THAT THE CUSTOMER PASSED AWAY AT HOME ON (B)(6) 2015. THE CAUSE OF DEATH WAS CORONARY HEART DISEASE/ HYPERLIPIDEMIA. THE CUSTOMER WAS IN THE HOSPITAL ON (B)(6) 2015 FOR NINE DAYS FOR HBI. ALSO, THE CUSTOMER'S BODY WAS SEPTIC DUE TO BACTERIAL INFECTION. THE CUSTOMER HAD TYPE I DIABETES AND HEART DISEASE. THE CUSTOMER'S LAST RECORDED BLOOD GLUCOSE VALUE WAS 545 MG/DL ON (B)(6) 2015 AT 2:40 AM. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER USED SENSORS ONLY FOR FOUR DAYS IN (B)(6) 2014 AND THAT WAS IT. NO SENSOR WAS WORN AT THE TIME OF DEATH. THE CALLER STATED THAT THE CUSTOMER'S PASSING WAS SUDDEN; NO SYMPTOMS OR ANYTHING - HE WAS FINE AND THEN HE PASSED AWAY. THE CALLER AGREED TO RETURN THE INSULIN PUMP FIR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755428 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR