BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 5040351 · Received August 28, 2015

    Report

    Report Number
    2032227-2015-38286
    Event Type
    Death
    Date Received
    August 28, 2015
    Date of Event
    July 6, 2015
    Report Date
    August 27, 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. THE CALLER STATED THE CAUSE OF DEATH IS NOT YET KNOWN; THEY ARE WAITING FOR THE TOXICOLOGY REPORT. THE CALLER STATED THAT WHEN THE CUSTOMER WAS FOUND, IT LOOKED AS IF HE HAD BEEN TRYING TO USE HIS INSULIN PUMP. THE CALLER DID NOT KNOW THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF DEATH. SINCE THE CALLER THREW AWAY THE INSULIN PUMP AFTER THE CUSTOMER'S PASSING AND GAVE AWAY ALL OF THE OTHER SUPPLIES, THE CUSTOMER'S LAST RECORDED BLOOD GLUCOSE COULD NOT BE CHECKED IN THE INSULIN PUMP OR THE BLOOD GLUCOSE METER. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CALLER WAS UNSURE ABOUT THE CUSTOMER'S USE OF SENSORS AND STATED THAT SHE DOESN'T THINK THE CUSTOMER WAS WEARING A SENSOR AT THE TIME OF DEATH. SINCE THE CALLER THREW AWAY THE INSULIN PUMP, THE DEVICE INFORMATION COULD NOT BE VERIFIED. THE INSULIN PUMP INFORMATION USED ON THIS MEDWATCH REPORT IS THE LAST KNOWN INSULIN PUMP TO HAVE BEEN ISSUED TO THE DECEDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570687 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death