BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5036041 · Received August 27, 2015

    Report

    Report Number
    2032227-2015-36574
    Event Type
    Death
    Date Received
    August 27, 2015
    Date of Event
    June 25, 2015
    Report Date
    August 19, 2015
    Manufacturer
    MEDTRONIC MINIMED
    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 THE CUSTOMER PASSED AWAY IN A HOSPITAL. HE WAS HOSPITALIZED ON (B)(6) 2015, FOR BACK SURGERY. CUSTOMER WAS IN A BAD CAR ACCIDENT. HE WAS THE DRIVER, BUT THE ACCIDENT WAS NOT DIABETES OR INSULIN PUMP RELATED. AT THE TIME OF THE ACCIDENT, HIS BACK HAD TOTALLY COLLAPSED. UPON ADMISSION TO THE HOSPITAL ON (B)(6) 2015, THE CUSTOMER WAS TAKEN OFF OF THE INSULIN PUMP, BECAUSE THE DOCTORS DETERMINED IT WAS EASIER FOR THEM TO CONTROL THE CUSTOMER'S DIABETES WHILE HE WAS IN THE HOSPITAL. THE CAUSE OF DEATH WAS ARDS, SEPSIS AND SEVERE INFECTION. THE CUSTOMER HAD KIDNEY FAILURE BECAUSE OF THE INFECTION, HAD HEART DISEASE, AND HAD A HEART ATTACK THE YEAR BEFORE. THE CALLER DID NOT KNOW THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CALLER DIDN'T KNOW HOW LONG THE INSULIN PUMP WAS DISCONNECTED BEFORE PASSING. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER DOESN'T KNOW WHERE THE INSULIN PUMP IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569080 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death