BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 23345497 · Received October 21, 2025

    Report

    Report Number
    2032227-2025-287495
    Event Type
    Death
    Date Received
    October 21, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 28, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300096003201
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    UPDATED SUMMARY : IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER PASSED AWAY ON (B)(6) 2025. THE CUSTOMER WAS ADMITTED TO A HOSPITAL PRIOR TO THE REPORTED INCIDENT. THE CAUSE OF DEATH WAS HYPOGLYCEMIA, HEART FAILURE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 54 MG/DL. THE EVENT INVOLVED PRODUCT(S) UNOMEDICAL, UNK_RESERVOIR, MMT-1884. TROUBLESHOOTING WAS PERFORMED AND PUMP WAS IN USAGE WITHIN 48HRS AND IT WAS UNKNOWN WEATHER THE AUTO MODE FEATURE WAS USED. NO PRODUCT RETURN IS REQUIRED FOR UNOMEDICAL, UNK_RESERVOIR, MMT-1884.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER PASSED AWAY ON (B)(6) 2025. THE CUSTOMER WAS ADMITTED TO A HOSPITAL PRIOR TO THE REPORTED INCIDENT. THE CAUSE OF DEATH WAS HYPOGLYCEMIA, HEART FAILURE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 54 MG/DL. THE EVENT INVOLVED PRODUCT(S) UNOMEDICAL, UNK RESERVOIR, MMT-1884. TROUBLESHOOTING WAS NOT PERFORMED. IT WAS UNKNOWN THAT THE PUMP WORN AT THE TIME OF DEATH. NO PRODUCT RETURN IS REQUIRED FOR UNOMEDICAL, UNK RESERVOIR, MMT-1884.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999137 MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1884 NG4194669H 000076300096003201

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Other| D FRN-UNK-RSVR, UNOMED INF SET.