BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3222952 · Received July 12, 2013

    Report

    Report Number
    2032227-2013-02857
    Event Type
    Death
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    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

    CUSTOMER'S MOTHER CALLED TO REPORT THE DEATH. CALLER STATED THAT THERE WAS NOT EVENTS LEADING UP TO THE PASSING OF HER SON. CAUSE OF DEATH WAS CARDIAC ARREST AND HYPOGLYCEMIA. CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323935 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death