BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3120998 · Received May 20, 2013

    Report

    Report Number
    2032227-2013-01995
    Event Type
    Death
    Date Received
    May 20, 2013
    Date of Event
    January 22, 2012
    Report Date
    May 15, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    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. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY LAST YEAR. IT WAS STATED THAT THE CAUSE OF DEATH MAY HAVE HAD SOMETHING TO DO WITH DIABETES AS HE WAS DIABETIC FOR 51 YEARS. HOWEVER THE CUSTOMER ALSO HAD HEART PROBLEMS, AND IT JUST STOPPED. IT WAS STATED THAT THE CUSTOMER HAD THREE HEART ATTACKS IN HIS LIFE TIME, AND HAD CONGESTIVE HEART FAILURE SINCE 2005. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222639 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LCAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Death