BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4133755 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-32278
    Event Type
    Death
    Date Received
    October 1, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    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 AN UNKNOWN CAUSE. THE CUSTOMER'S SON DID NOT KNOW THE BLOOD GLUCOSE READING AT THE TIME OF DEATH. HE STATED THAT HIS MOTHER HAD EXPERIENCED HIGH AND LOW BLOOD GLUCOSE LEVELS DUE TO NOT BEING ABLE TO GRASP THE CONCEPT OF USING THE INSULIN PUMP. HE REPORTED THAT SHE WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH AND THAT IT HAD BEEN FOUND ON THE COFFEE TABLE BESIDE HER. HE WAS UNSURE HOW LONG SHE HAD BEEN DISCONNECTED FROM THE DEVICE BUT NOTED THAT SHE WAS IN THE MIDDLE OF CHANGING AN INFUSION SET WHILE SHE HAD IT DISCONNECTED. HE STATED HE WAS 99 PERCENT SURE THAT EMERGENCY WORKERS DID NOT REMOVE THE INSULIN PUMP FROM THE CUSTOMER AT THE TIME OF DEATH. THE INSULIN PUMP COULD NOT BE RETURNED FOR ANALYSIS BECAUSE THE CALLER HAD DISCARDED THE DEVICE ALONG WITH THE BLOOD GLUCOSE METER. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610926 INSULIN INFUSION PUMP CGM MDS MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death