BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 23529700 · Received November 12, 2025

    Report

    Report Number
    2032227-2025-298689
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    October 17, 2025
    Report Date
    January 23, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Removal / Correction Number
    2032227-07-23-2024-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. PUMP PASSED THE SELF TEST, SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT. PUMP WAS MONITORED, NO BLANK DISPLAY AND UNEXPECTED BATTERY POWER LOSS NOTED. SUCCESSFULLY DOWNLOADED PUMP TRACES AND HISTORY FILE USING THUMP. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. LOW BATTERY ALERT WAS FOUND ON: (B)(6) 2025 16:40:01.000. REPLACE BATTERY ALERT WAS FOUND ON: (B)(6) 2025 02:11:00.000 TO (B)(6) 2025 04:41:03.000. INSERT BATTERY ALARM WAS FOUND ON: (B)(6) 2025 03:17:18.000 TO (B)(6) 2025 03:57:36.000, (B)(6) 2025 04:02:36.000 TO (B)(6) 2025 04:41:03.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: (B)(6) 2025 03:17:26.000 TO (B)(6) 2025 03:57:26.000, (B)(6) 2025 04:02:17.000 TO (B)(6) 2025 04:40:53.000. REPLACE BATTERY NOW ALARM WAS FOUND ON: (B)(6) 2025 02:42:00.000, (B)(6) 2025 02:52:00.000, (B)(6) 2025 04:23:07.000 TO 10/17/2025 04:40:45.000. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, LOW BATTERY ALERT, REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM AND FAILED BATTERY ALERT/BATTERY FAILED ALARM WERE EXPECTED SINCE THE BATTERY IN THE PUMP IS LOW ON POWER OR DOES NOT HAVE ENOUGH POWER. THE CUSTOMER HAD USED A LOW/NO POWER BATTERY. NO UNEXPECTED LOW BATTERY ALERT, REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM AND FAILED BATTERY ALERT/BATTERY FAILED ALARM NOTED DURING TESTING. IN FURTHER CHECKING OF THE PUMP HISTORY RECORDS: BATTERY CYCLE 1 RECEIVED THE LOWBATTERYALERT (104) ON (B)(6) 2025 16:40:01 AFTER MORE THAN 7 DAYS AT 10.64 DAYS. BATTERY CYCLE 2 RECEIVED THE LOWBATTERYALERT (104) ON (B)(6) 2025 15:29:01 AFTER MORE THAN 7 DAYS AT 11.21 DAYS. BATTERY CYCLE 3 RECEIVED THE LOWBATTERYALERT (104) ON (B)(6) 2025 00:21:00 AFTER MORE THAN 7 DAYS AT 9.32 DAYS. WITH REFERENCE TO THE BAAT TOOL INSTRUCTIONS, CUSTOMER DID NOT EXPERIENCE AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK PRIOR TO THE EVENT DATE OF 17-OCT-2025, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: SENSOREXPIREDALERT (794) WAS FOUND ON: (B)(6) 2025 17:32:35.000. THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (3) TRANSMITTER AND A GLUCOSE SENSOR SIMULATOR. THE PUMP CONNECTED SUCCESSFULLY TO THE TRANSMITTER AND DISPLAYED ¿TRANSMITTER CONNECTION SUCCESSFUL¿. THE PUMP COMMUNICATED PROPERLY WITH GLUCOSE SENSOR SIMULATOR AND DISPLAYED THE CALIBRATE YOUR SENSOR ALARM PROPERLY AFTER COMPLETION OF THE WARMUP. THE PUMP CALIBRATED AND DISPLAYED THE PROGRAMMED VALUE OF 240 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO SENSOR EXPIRED ALERT OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND IT WAS VERIFIED THAT THE BATTERY TUBE POWER CONNECTOR IS PROPERLY CONNECTED TO J7/PCB1. HOWEVER, CORROSION WAS FOUND ON THE PCBA 1 AND PCBA 2. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A MISSING DISPLAY WINDOW/COVER, A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT AND A BROKEN BELT CLIP RAILS. THE PUMP PASSED ALL THE REQUIRED TESTING. CUSTOMER ALLEGED FOR BLANK DISPLAY AND UNEXPECTED BATTERY POWER LOSS WERE NOT CONFIRMED. HOWEVER, DURING VISUAL INSPECTION CORROSION WAS FOUND ON THE PCBA 1 AND PCBA 2. 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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 EXPERIENCED BLANK DISPLAY AND PUMP WAS NOT TURNING ON. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884. TROUBLESHOOTING WAS PERFORMED. BATTERY CAP CONTACTS AND BATTERY COMPARTMENT AND/OR SPRINGS ARE NOT DAMAGED. DISPLAY DID NOT RETURN AFTER INSERTING A NEW BATTERY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1884 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. THE CUSTOMER WILL DISCONTINUE USING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2543865 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 NG3598813H

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female