BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 24360871 · Received February 16, 2026

    Report

    Report Number
    2032227-2026-128320
    Event Type
    Injury
    Date Received
    February 16, 2026
    Date of Event
    January 26, 2026
    Report Date
    March 16, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300096003201
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST, AND THE DAT AT 0.0874 INCHES. NO CRACKED BATTERY TUBE THREADS OR CRACKED CASE AT THE BATTERY TUBE SIDE NOTED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. THE PUMP WAS RECEIVED WITHOUT A BATTERY. NO DAMAGE NOTED ON THE BATTERY CAP. UNABLE TO VERIFY CUSTOMER'S DAILY TOTAL OF ALL INSULIN DELIVERED, DAILY TOTAL OF BASAL INSULIN DELIVERED AND DAILY TOTAL OF BOLUS INSULIN DELIVERED ON THE EVENT DATE 26-JAN-2026 LISTED ON SMARTSOLVE DUE TO INSUFFICIENT DATA IN THE TRACE/HISTORY FILES. PERFORM THE HISTORY REVIEW 1 WEEK FROM THE EVENT DATE 26-JAN-2026 IN THE PUMP HISTORY FILE AND FOUND 1 LOWBATTERYALERT (104) ON (B)(6) 2026 00:11:00.000, 1 SENSORERRORALERT (801) ON (B)(6) 2026, 1 NODELIVERY (7) ALARM ON (B)(6) 2026 19:40:50.000 (DURING BOLUS), 1 PUMP ERROR 23 ON (B)(6) 2026, AND 2 BATTOUTLIMIT (6) ON (B)(6) 2026. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. LOW BATTERY ALERT WAS EXPECTED DUE TO THE CUSTOMER'S BATTERY IN THE PUMP IS LOW ON POWER. PUMP ERROR 23 AND BATTERY OUT LIMIT ALARM WERE EXPECTED DUE TO THE BATTERY REMOVED FOR MORE THAN 10 MINUTES AND THE PUMP RESET. THE PUMP PROPERLY PAIRED WITH THE GUARDIAN LINK 4 TRANSMITTER. NO SENSOR ERROR ALERT NOTED DURING TESTING. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (22.9 MV). THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED HIGH BGS. DAMAGE- CRACKED CASE BATTERY TUBE NOT CONFIRMED AT THE BACK OF THE PUMP, HOWEVER, OTHER COSMETIC DAMAGE WAS NOTED DURING ANALYSIS. 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.

    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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 CALLED ABOUT EXPERIENCING A HIGH BLOOD GLUCOSE (BG) EVENT YESTERDAY, WITH A BG VALUE OF 400 MG/DL. THE EVENT INVOLVED PRODUCT(S) MMT-1884,MMT-431AJ,MMT-342,MMT-5120A. THE CUSTOMER HAS TYPE 1 DIABETES AND MANAGED THE HIGH BG USING THE PUMP. THE HIGH BG PERSISTED FOR MORE THAN FOUR HOURS AND IS NO LONGER OCCURRING. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER WAS USING THE MINIMED 670G/770G/780G SYSTEM WITH THE AUTO MODE/SMARTGUARD FEATURE ACTIVE AT THE TIME OF THE EVENT. A CRACK ON THE CASE AT THE BATTERY TUBE SIDE. THE DAMAGE DID NOT OCCUR OUT OF THE BOX, THERE IS NO DAMAGE TO THE RETAINER RING, AND THE CRACK OCCURRED WHILE USING A SILICONE CASE. THE DAMAGE IS NOT CURRENTLY IMPACTING PUMP FUNCTIONALITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. MMT-1884,MMT-431AJ,MMT-342,MMT-5120A WERE NOT EXPECTED TO RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247163 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 NG4185692H 000076300096003201

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Other FRN-MMT-342-RSVR, UNOMED INF SET.| SFI-MMT-5120A-SNSR.