BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3930320 · Received July 11, 2014

    Report

    Report Number
    2032227-2014-03567
    Event Type
    Death
    Date Received
    July 11, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 2, 2014
    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 SON REPORTED HIS MOTHER'S DEATH. CALLER STATED THAT CUSTOMER HAD A LOT OF HEALTH CONCERNS. THE CAUSE OF DEATH WAS HEART PROBLEMS, DIABETES AND A PREVIOUS STROKE. CUSTOMER HAD VOMITED ON HER SHIRT. CALLER IS NOT SURE IF HIS MOTHER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406712 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death