BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2112416 · Received May 24, 2011

    Report

    Report Number
    2032227-2011-01310
    Event Type
    Death
    Date Received
    May 24, 2011
    Date of Event
    May 15, 2011
    Report Date
    May 19, 2011
    Manufacturer
    MEDTRONIC MINIMED
    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 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. 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 DUE TO NATURAL CAUSES. THE HUSBAND FELT THAT THE CAUSE OF DEATH WAS DIABETES. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE HUSBAND STATED THAT HE CANNOT RETURN THE INSULIN PUMP FOR ANALYSIS AT THIS TIME AS IT HAS NOT BEEN RETURNED BY THE HOSPITAL OR FUNERAL HOME. HE STATED THAT HE WOULD RETURN IT FOR ANALYSIS IF IS RETURNED TO HIM. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death