BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME INSUILN INFUSION PUMP

    MDR report key: 2200714 · Received August 3, 2011

    Report

    Report Number
    2032227-2011-01892
    Event Type
    Death
    Date Received
    August 3, 2011
    Date of Event
    July 9, 2011
    Report Date
    July 28, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    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. THE CAUSE OF DEATH WAS REPORTED AS A HEART ATTACK CAUSED BY DIABETES. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE REPORTER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death