BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRDGM INSULIN PUMP

    MDR report key: 7839574 · Received August 31, 2018

    Report

    Report Number
    2032227-2018-21979
    Event Type
    Death
    Date Received
    August 31, 2018
    Date of Event
    January 23, 2018
    Report Date
    August 31, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 AN UNKNOWN LOCATION ON (B)(6) 2018. THE CAUSE OF DEATH WAS AN INSULIN OVERDOSE. THE REPORTER STATED THE INSULIN PUMP HAD RESET AND THE SETTING WAS CHANGED FROM "GRAMS" TO "UNITS", CAUSING AN INCORRECT BOLUS TO BE GIVEN. THE CUSTOMER EXPERIENCED HYPOGLYCEMIA LEADING TO THE DEATH. IT WAS UNKNOWN IF THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. IT WAS UNKNOWN IF THE CUSTOMER WAS USING SENSORS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS. FRN- MODEL UNKNOWN ¿ RESERVOIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681034 PRDGM INSULIN PUMP PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 Death