BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2082631 · Received April 28, 2011

    Report

    Report Number
    2032227-2011-01070
    Event Type
    Death
    Date Received
    April 28, 2011
    Date of Event
    September 20, 2011
    Report Date
    April 22, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 INFO 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 AT HER HOME FROM DIABETES COMPLICATIONS. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CALLER ALSO SHARED THAT THE CUSTOMER EXPERIENCED KIDNEY PROBLEMS AS WELL AS NUMEROUS INTERNAL COMPLICATIONS. THE CALLER 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 INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death