BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 23679321 · Received December 1, 2025

    Report

    Report Number
    2032227-2025-309310
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    November 3, 2025
    Report Date
    April 7, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300096003201
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    UNIT PASSED THE SELF-TEST, DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST AND OCCLUSION TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARMS NOTED DURING TESTING. UNIT SUCCESSFULLY DOWNLOADED TO THUMP. CONFIRMED PUMP ALARMED INSULIN FLOW BLOCKED ALARM ON 11/02/2025 06:28:41.000 BOLUS, 11/02/2025 19:04:31.000 BOLUS, 11/02/2025 19:08:11.000 BOLUS, 11/02/2025 19:13:01.000 BOLUS AND 11/02/2025 19:23:29.000 BOLUS IN PUMP DOWNLOADED HISTORY DURING BOLUS. THE PUMP WAS CUT TO PERFORM VISUAL INSPECTION AND FOUND NO PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR AND MOTOR HOME SWITCH. THE SC1 CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: PILLOWING KEYPAD OVERLAY, STAINED KEYPAD OVERLAY AND SCRATCHED CASE. UNEXPECTED INSULIN FLOW BLOCKED ALARM WAS NOT CONFIRMED. COSMETIC DAMAGES WERE NOTED DURING VISUAL INSPECTION. 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

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED AN INSULIN FLOW BLOCKED ALARM. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884. TROUBLESHOOTING WAS PERFORMED. CUSTOMER CONFIRMED INSULIN DID NOT EXIT DURING 5U FILL CANNULA OR PUMP ALARMED. CUSTOMER RE-ATTEMPTED LOAD RESERVOIR/FILL TUBING PROCESS AFTER A COMPLETE SET CHANGE AND INSULIN DID NOT EXIT OR PUMP ALARMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1884 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WOULD BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2265802 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 NG4194339H 000076300096003201

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown