BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 23035272 · Received September 12, 2025

    Report

    Report Number
    2032227-2025-257425
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 18, 2025
    Report Date
    October 29, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH WAS NOT INCLUDED IN THE INITIAL REPORT. THE UPDATED INFORMATION HAS BEEN PROVIDED IN BELOW SECTIONS WITH THIS FOLLOW-UP REPORT. 1. SECTION B5 - UPDATED SUMMARY. 2. SECTION H6 - ADDED FDA DEVICE PROBLEM CODE AS REMOVED 1184 CODE. 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

    THE PUMP PASSED THE FUNCTIONAL TESTS, 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 DAT WITHIN SPECIFICATION AT .08690 INCHES. THE PUMP WAS MONITORED, NO PUMP ERROR 82 ALARM, FAILED BATTERY ALERT/BATTERY FAILED ALARM AND FLASHING MEDTRONIC LOGO NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES 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 18:26:00.000. INSERT BATTERY ALARM WAS FOUND ON: (B)(6) 2025 18:27:00.000. (B)(6) 2025 18:27:24.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: (B)(6) 2025 18:26:33.000, (B)(6) 2025 18:26:50.000. (B)(6) 2025 18:27:00.000, (B)(6) 2025 18:27:09.000. (B)(6) 2025 18:27:24.000, (B)(6) 2025 18:27:34.000. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON (B)(6) 2025 AT 08:07:58 AM. THERE WAS NO POWER DATA AVAILABLE FOR THE EVENT DATE OF (B)(6) 2025. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT AND FAILED BATT/BATTERY FAILED ALARM. NO UNEXPECTED LOW BATTERY ALERT AND FAILED BATT/BATTERY FAILED ALARM NOTED DURING TESTING. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK PRIOR TO THE EVENT DATE OF (B)(6) 2025, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: LOSTSENSOR1ALERT (780) WAS FOUND ON: (B)(6) 2025 12:08:00.000. (B)(6) 2025 12:18:00.000. 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 WARM UP. THE PUMP CALIBRATED AND DISPLAYED THE PROGRAMMED VALUE OF 240 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO LOST SENSOR ALERT OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. THERE IS NO PUMP ERROR 82 ALARM RECORDED IN THE DETAILED TRACE FILE. HOWEVER, PUMP ERROR 82 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON (B)(6) 2025 18:26:04.000, INDICATING THAT THE POWER WAS GRANTED TO THE MOTOR MICROCONTROLLER BY THE MAIN MICROCONTROLLER AFTER THE PUMP ERROR 82 OCCURRENCE. DURING SELF TEST, THE RED LED INDICATOR TURNED ON AND THE VIBRATOR MOTOR VIBRATED WITH BOTH FUNCTIONING PROPERLY WHICH INDICATES THE HARDWARE WORKED AS EXPECTED. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.13MV). THE TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY AND A SCRATCHED CASE. THE PUMP PASSED ALL THE REQUIRED TESTING. CUSTOMER ALLEGED FOR FAILED BATTERY ALERT/BATTERY FAILED ALARM AND FLASHING MEDTRONIC LOGO WERE NOT CONFIRMED. PUMP ERROR 82 ALARM WAS CONFIRMED, HOWEVER UNABLE TO CONFIRM FOR SOFTWARE ANOMALY DUE TO INSUFFICIENT DATA IN THE DETAIL TRACE FILE, EARLIEST DATA RECORDED WAS ON (B)(6) 2025 08:07:11.000. PUMP ERROR 82 ALARM, PROBLEM ISOLATED TO THE (B)(4). 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

    UPDATED SUMMARY: CUSTOMER REPORTED THAT PUMP FLASHING MEDTRONIC LOGO.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER RECEIVED PUMP ERROR 82 (THE HRM TASK DID NOT GRANT MOTOR POWER IN A REASONABLE TIME) AND BATTERY FAILED ALARM. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884. TROUBLESHOOTING WAS PERFORMED FOR THE PUMP ERROR, AND THE CUSTOMER WAS ABLE TO CLEAR THE ERROR, BUT WAS UNABLE TO COMPLETE THE REWIND PROCESS. TROUBLESHOOTING WAS PERFORMED FOR THE BATTERY FAILED ALARM, AND NO DAMAGE WAS REPORTED ON THE BATTERY CAP CONTACTS OR BATTERY COMPARTMENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS INSTRUCTED TO DISCONTINUE DEVICE USE AND REVERT TO THE BACKUP PLAN WITH THE HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. MMT-1884 WAS REQUESTED, AND THE CUSTOMER'S RESPONSE WAS THAT THE DEVICE WOULD BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2676537 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 NG3501880H

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male