BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2041271 · Received March 29, 2011

    Report

    Report Number
    3004209178-2011-80854
    Event Type
    Death
    Date Received
    March 29, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 17, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD PASSED AWAY. THE CUSTOMER'S SISTER STATED THAT THE CUSTOMER HAD BEEN WEARING HIS INSULIN PUMP AT THE TIME OF PASSING. IT WAS STATED THAT THE AUTOPSY REPORT STATED THE CAUSE OF DEATH TO BE DUE TO COMPLICATIONS OF DIABETES. THE CUSTOMER'S SISTER ALSO STATED THAT PRIOR TO THE EVENT, THE CUSTOMER HAD NOT BEEN FEELING WELL BUT HAD DIED BEFORE PARAMEDICS COULD ARRIVE. THE CUSTOMER'S SISTER FURTHER STATED THAT THE CUSTOMER HAD REFUSED TO GO TO THE HOSPITAL WHEN HE WAS NOT FEELING WELL AND THAT THE FAMILY HAD ASSUMED THAT HE HAD THE STOMACH FLU. NOTHING FURTHER WAS REPORTED.

    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 OPERATIONS MED-REL MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death