BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 2962329 · Received February 14, 2013

    Report

    Report Number
    2032227-2013-00616
    Event Type
    Death
    Date Received
    February 14, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 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

    THE FOLLOWING WAS POSTED ON A SOCIAL MEDIA SITE BY THE CUSTOMER'S BOYFRIEND: MY GIRLFRIEND OF TEN YEARS HAD TYPE 1 AND GOT THE PUMP. TWO WEEKS AFTER SHE GOT IT, SHE WAS DEAD. UNABLE TO FOLLOW UP WITH THE BOYFRIEND AS THERE WAS NOT ENOUGH PERSONAL IDENTIFYING INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65256 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 Death