BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2895679 · Received January 3, 2013

    Report

    Report Number
    3004209178-2013-90054
    Event Type
    Death
    Date Received
    January 3, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 31, 2012
    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 PASSED AWAY WHILE WEARING THE INSULIN PUMP. THE WIFE STATED THAT THE CAUSE OF DEATH IS UNKNOWN. ATTEMPTED TO CONTACT THE CALLER DAYS LATER AND THE CUSTOMER'S SON STATED THAT THE DEATH WAS POSSIBLE RELATED TO COMPLICATIONS FROM DIABETES, BUT HE DOES NOT WANT TO DISCUSS FURTHER ISSUES AND HE DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3346 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death