BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3100634 · Received May 8, 2013

    Report

    Report Number
    2032227-2013-01746
    Event Type
    Death
    Date Received
    May 8, 2013
    Date of Event
    February 10, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. 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 CARBON MONOXIDE POISONING. THE CUSTOMER'S LAST KNOWN BLOOD GLUCOSE READING WAS REPORTED AS -1 MG/DL. THE MOTHER STATED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE MOTHER WILL NOT BE RETURNING THE INSULIN PUMP FOR ANALYSIS AS SHE HAS DECIDED TO DONATE IT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201808 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Death