BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3120996 · Received May 20, 2013

    Report

    Report Number
    2032227-2013-02010
    Event Type
    Death
    Date Received
    May 20, 2013
    Date of Event
    March 9, 2012
    Report Date
    April 26, 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 CUSTOMER'S MOTHER CALLED IN TO REPORT HIS PASSING. IT WAS STATED THAT THE CUSTOMER WAS IN THE HOSPITAL PRIOR TO HIS DEATH. THE CUSTOMER WAS RELEASED ON (B)(6) 2013 IN FAIR CONDITION AND ON VARIOUS MEDICATIONS, BUT DIED FOUR DAYS LATER. IT WAS STATED THAT HIS FRIEND FOUND HIM ON THE FLOOR. ONE OF THE CAUSES OF DEATH WAS DIABETIC KETOACIDOSIS. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH, BUT IT WAS NOT KNOWN HOW LONG HE HAD NOT BEEN WEARING IT. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221537 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death