BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2021827 · Received March 8, 2011

    Report

    Report Number
    3004209178-2011-80604
    Event Type
    Death
    Date Received
    March 8, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 4, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD COMMITTED SUICIDE USING HIS INSULIN PUMP. AT PRESENT, THE INSULIN PUMP IS WITH THE POLICE DEPARTMENT AND WE ARE NOT EXPECTING THE INSULIN PUMP BACK AT THIS TIME AS THE INVESTIGATION IS STILL BEING CONDUCTED. 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 PUERTO RICO OPERATIONS MED-REL MMT-715WWL

    Patients

    Seq Age Sex Outcome Treatment
    1 Death