BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2101728 · Received May 20, 2011

    Report

    Report Number
    3004209178-2011-81570
    Event Type
    Death
    Date Received
    May 20, 2011
    Date of Event
    March 22, 2011
    Report Date
    May 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD PASSED AWAY IN HER SLEEP FROM A SEIZURE, WHILE WEARING HER INSULIN PUMP. THE CUSTOMER'S FATHER STATED THAT PRIOR TO THE EVENT, HE HAD FOUND THE CUSTOMER LYING ON THE FLOOR UNABLE TO SEE OR STAND, AND HAVING A HARD TIME SPEAKING. WHEN THE CUSTOMER'S FATHER CHECKED ON THE CUSTOMER LATER, SHE WAS FEELING BETTER AND WAS ABLE TO SPEAK BETTER AS WELL. THE CUSTOMER'S FATHER THEN STATED THAT THE CUSTOMER HAD REFUSED TO GO TO THE HOSPITAL AND WHEN HE WOKE UP THE NEXT MORNING HE FOUND THAT THE CUSTOMER HAD PASSED AWAY ALREADY. 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-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death