BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2243356 · Received September 6, 2011

    Report

    Report Number
    3004209178-2011-82853
    Event Type
    Death
    Date Received
    September 6, 2011
    Date of Event
    July 13, 2011
    Report Date
    August 24, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATION MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 WHILE WEARING THE INSULIN PUMP. THE MOTHER STATED THAT THE CAUSE OF THE CUSTOMER'S DEATH WAS DIABETES RELATED. ATTEMPTED TO CALL THE CUSTOMER'S MOTHER TWICE WITHOUT RESULTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATION MED-REL MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Death