BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2111666 · Received May 26, 2011

    Report

    Report Number
    2032227-2011-01322
    Event Type
    Death
    Date Received
    May 26, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 20, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    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. 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 DUE TO DIABETES MELLITUS, HYPERTENSION AND ATHEROSCLEROTIC CARDIOVASCULAR DISEASE. THE BLOOD GLUCOSE READING WAS UNKNOWN. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. PRIOR TO GOING TO BED, THE CUSTOMER WAS UNCOMFORTABLE WITH THE INSULIN PUMP, AND REMOVED IT FROM HIS BODY. THE CALLED AGREED 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 INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death