BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3951282 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-88085
    Event Type
    Death
    Date Received
    July 22, 2014
    Date of Event
    January 9, 2012
    Report Date
    July 8, 2014
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER PASSED AWAY. THE CAUSE OF DEATH WAS MASSIVE HEART ATTACH. NEITHER THE BLOOD GLUCOSE AT THE TIME OF DEATH NOR THE LAST RECORDED BLOOD GLUCOSE WERE KNOWN. THE CUSTOMER WASN'T FEELING WELL FOR ABOUT A YEAR PRIOR TO DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CALLER STATED THAT THERE WERE A COUPLE OF INCIDENTS WHEN THE INFUSION SET DIDN'T INSERT INTO THE BODY CAUSING INSULIN TO LEAK AT THE SITE. THERE WERE SEVERAL NO DELIVERY ALARMS THROUGHOUT THE ENTIRE TIME THE CUSTOMER USED THE DEVICE, BUT NONE PRIOR TO THE DEATH. BOTH ISSUES LED TO BLOOD GLUCOSE OF OVER 500 MG/DL WHICH WERE TREATED AND THE BLOOD GLUCOSE WAS STABILIZED. THE CALLER STATED THAT THE CUSTOMER WAS BECOMING INSULIN RESISTANT IN THE LAST FEW YEARS AND WAS NON SYMPTOMATIC TO THE HIGH AND LOW BLOOD GLUCOSE INCIDENTS. THE INSULIN PUMP AND THE SUPPLIES WERE GIVEN TO A NEIGHBORHOOD GIRL AFTER THE CUSTOMER'S DEATH. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428627 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death