BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3120993 · Received May 20, 2013

    Report

    Report Number
    2032227-2013-02004
    Event Type
    Death
    Date Received
    May 20, 2013
    Date of Event
    December 20, 2012
    Report Date
    April 25, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    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 A HEART ATTACK. IT WAS STATED THAT THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH, BUT IT WAS NOT KNOWN HOW LONG SHE HAD BEEN OFF OF IT. IT WAS STATED THAT THE CUSTOMER WAS ON DIALYSIS, AND HAD HEART PROBLEMS. THE CALLER WILL NOT BE RETURNING THE INSULIN PUMP AS SHE DOESN'T KNOW WHERE IT IS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221887 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Death