BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4910681 · Received July 13, 2015

    Report

    Report Number
    2032227-2015-22010
    Event Type
    Death
    Date Received
    July 13, 2015
    Date of Event
    November 23, 2014
    Report Date
    July 7, 2015
    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 AT HOME, IN HIS SLEEP. THE CALLER DID NOT PROVIDE THE CAUSE OF DEATH. SHE ONLY STATED THAT NOTHING WAS WRONG, EVERYTHING WAS HAS BEEN CHECKED; THE POLICE CHECKED THE MEDICATION. THE CALLER STATED THAT THE CUSTOMER HAD TRIPLE BYPASS. THE CALLER ALSO STATED THAT SHE SAW THE INSULIN PUMP ONLY ONCE OR TWICE. SHE NEVER SAW THE TUBING. THE CUSTOMER KEPT IT HIDDEN UNDER HIS ROBE. WHEN ASKED IF THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH, THE CALLER STATED THAT SHE NEVER SAW THE INSULIN PUMP. THE CALLER WAS BECAME UPSET AND STARTED CRYING. SHE STATED THAT THE CUSTOMER'S DOCTOR SHOULD BE CONTACTED FOR FURTHER INFORMATION. THE DOCTOR'S OFFICE WAS CONTACTED BUT THEY DID NOT PROVIDE ANY INFORMATION, STATING THAT THEY CANNOT GIVE ANY INFORMATION WITHOUT A WRITTEN STATEMENT FORM THE FAMILY, AND THEY DO NOT HAVE THAT INFORMATION, SO NO INFORMATION CAN BE PROVIDED. THE INSULIN CALLER NO LONG HAD THE INSULIN PUMP FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453116 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death