BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4140853 · Received October 3, 2014

    Report

    Report Number
    2032227-2014-33191
    Event Type
    Death
    Date Received
    October 3, 2014
    Date of Event
    September 28, 2014
    Report Date
    October 1, 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 THE CUSTOMER HAD PASSED AWAY. AT THE TIME OF DEATH, THE CUSTOMER'S BLOOD GLUCOSE WAS 50 MG/DL. THE CALLER STATED THAT THE CUSTOMER'S INSULIN PUMP WAS IN THE CUSTOMER'S BELONGINGS. THE CALLER DID NOT KNOW THE TYPE OF THE BLOOD GLUCOSE METER THAT THE CUSTOMER HAD BEEN USING. THE CALLER STATED THAT THE CUSTOMER HAD BEEN IN THE HOSPITAL FOR TWO AND A HALF MONTHS AND PASSES AWAY IN THE INTENSIVE CARE UNIT. THE CAUSE OF DEATH WAS LIVER FAILURE, MENINGITIS, AND BOWEL DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH AND HAD BEEN DISCONNECTED FROM THE DEVICE SEVERAL WEEKS PRIOR TO PASSING. THE CUSTOMER HAD BEEN IN A DRIP. NOTHING FURTHER INFORMATION WAS OBTAINED DUE TO THE PHONE CALL BEING DISCONNECTED. CALL BACK ATTEMPT WAS MADE, BUT WAS UNSUCCESSFUL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620304 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death