BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 23120704 · Received September 23, 2025

    Report

    Report Number
    2032227-2025-266790
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    August 30, 2025
    Report Date
    November 24, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. THE PUMP WAS RECEIVED WITH A CRACKED BATTERY TUBE THREADS AND A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT. 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 .08715 INCHES. THE PUMP WAS MONITORED FOR SEVERAL HOURS, AND NO BLANK DISPLAY NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. ON THE EVENT DATE OF (B)(6) 2025, THERE IS NO UNEXPECTED ALARM(S)/SUSPENDS RECORDED IN THE FORMATTED HISTORY FILE. ON THE EVENT DATE OF (B)(6) 2025 AT 00:00:00.000 OF THE DAILY TOTAL COLLECTION START TIME, THE DAILY TOTAL OF BASAL INSULIN DELIVERED = 24750 (2.475 U) AND DAILY TOTAL OF BOLUS INSULIN DELIVERED = 179000 (17.9 U) WHICH IS EQUAL TO THE DAILY TOTAL OF ALL INSULIN DELIVERED = 203750 (20.375 U). ON THE EVENT DATE OF (B)(6) 2025 AT 03:35:58.000 OF THE DAILY TOTAL COLLECTION START TIME, THE DAILY TOTAL OF BASAL INSULIN DELIVERED = 369250 (36.925 U) AND DAILY TOTAL OF BOLUS INSULIN DELIVERED = 693000 (69.3 U) WHICH IS EQUAL TO THE DAILY TOTAL OF ALL INSULIN DELIVERED = 1062250 (106.225 U). ON THE EVENT DATE OF (B)(6) 2025 AT 21:05:31.000 OF THE DAILY TOTAL COLLECTION START TIME, THE DAILY TOTAL OF BASAL INSULIN DELIVERED = 26000 (2.6 U) AND DAILY TOTAL OF BOLUS INSULIN DELIVERED = 0 (0 U) WHICH IS EQUAL TO THE DAILY TOTAL OF ALL INSULIN DELIVERED = 26000 (2.6 U). ALL BOLUS/BASAL WERE DELIVERED IN AUTO MODE/MANUAL MODE. 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: MULTIPLE NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WERE FOUND ON (B)(6) 2025 DURING BOLUS/BASAL/PRIME DELIVERIES. 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. LOST SENSOR 1ALERT (780) WAS FOUND ON: (B)(6) 2025 07:36:00.000, (B)(6) 2025 15:41:00.000. (B)(6) 2025 01:41:00.000, (B)(6) 2025 08:51:00.000. (B)(6) 2025 11:01:00.000. (B)(6) 2025 10:08:00.000 (B)(6) 2025 10:18:00.000. (B)(6) 2025 02:30:00.000. LOST SENSOR 2ALERT (781) WAS FOUND ON: (B)(6) 2025 02:47:00.000. SENSOR ERROR ALERT (801) WAS FOUND ON: (B)(6) 2025 04:00:25.000, (B)(6) 2025 04:10:00.000. (B)(6) 2025 07:30:26.000, (B)(6) 2025 07:40:00.000. (B)(6) 2025 21:34:15.000, (B)(6) 2025 21:40:21.000. (B)(6) 2025 22:04:16.000 TO (B)(6) 2025 22:34:17.000. 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 LOST SENSOR ALERT, SENSOR ERROR ALERT OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. 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 18:55:00.000. REPLACE BATTERY ALERT WAS FOUND ON: (B)(6) 2025 04:26:00.000. (B)(6) 2025 04:36:00.000. REPLACE BATTERY NOW ALARM WAS FOUND ON: (B)(6) 2025 04:57:00.000. (B)(6) 2025 05:07:00.000. POWER LOSS ALARM WAS FOUND ON: (B)(6) 2025 05:14:07.000. (B)(6) 2025 03:35:45.000. (B)(6) 2025 18:51:32.000. (B)(6) 2025 21:03:47.000. INSERT BATTERY ALARM WAS FOUND ON: (B)(6) 2025 05:12:12.000. (B)(6) 2025 05:12:22.000. (B)(6) 2025 05:13:15.000 TO (B)(6) 2025 05:13:51.000. (B)(6) 2025 03:09:19.000 TO (B)(6) 2025 03:34:39.000. (B)(6) 2025 16:53:33.000. (B)(6) 2025 17:09:00.000. (B)(6) 2025 17:19:00.000. (B)(6) 2025 18:49:16.000 TO (B)(6) 2025 18:59:18.000. (B)(6) 2025 19:09:00.000. (B)(6) 2025 21:03:51.000 TO (B)(6) 2025 21:04:28.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: (B)(6) 2025 05:12:16.000. (B)(6) 2025 03:10:19.000. (B)(6) 2025 17:02:09.000. (B)(6) 2025 18:51:23.000 TO (B)(6) 2025 18:58:32.000. (B)(6) 2025 21:04:11.000. (B)(6) 2025 21:04:21.000. 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 13:39:58.000. THERE WAS NO POWER DATA AVAILABLE FOR THE DATES OF (B)(6) 2025. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS EXPECTED DUE TO PUMP BATTERY DOES NOT HAVE ENOUGH POWER. THE CUSTOMER HAD USED A NO POWER BATTERY. NO UNEXPECTED LOW BATTERY ALERT, REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM, POWER LOSS ALARM AND FAILED BATTERY ALERT/BATTERY FAILED ALARM NOTED DURING TESTING. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND IT WAS VERIFIED THAT THE BATTERY TUBE POWER CONNECTOR IS PROPERLY CONNECTED TO J7/PCB1. 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 (23.01MV). THE PUMP WAS RECEIVED WITHOUT A BATTERY. THE PUMP WAS RECEIVED WITHOUT A BATTERY CAP. THE TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY, A SCRATCHED CASE, A SERIAL NUMBER LABEL FADING AND A BROKEN BELT CLIP RAILS. COSMETIC DAMAGE WAS CONFIRMED AT THE CASE - BATTERY COMPARTMENT OF THE PUMP DURING ANALYSIS. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS. CUSTOMER ALLEGED FOR BLANK DISPLAY WAS NOT CONFIRMED. 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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED INSIDE THE UNITED STATES. 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 HYPERGLYCEMIA. THE CUSTOMER ALSO REPORTED THE INSULIN PUMP HAD A BLANK DISPLAY AND A CRACK ON THE BATTERY SIDE THAT AFFECTED THE INSULIN PUMP'S FUNCTIONALITY. BLOOD GLUCOSE VALUE AT THE TIME OF EVENT WAS 39 MMOL/L. THE CUSTOMER EXPERIENCED SYMPTOM OF FEELING SICK OR UNWELL DURING THE EVENT. THE CUSTOMER VISITED THE EMERGENCY ROOM AND WAS TREATED WITH A MANUAL INJECTION. THE EVENT INVOLVED PRODUCT(S) MMT-1885. TROUBLESHOOTING WAS PERFORMED FOR HIGH BLOOD GLUCOSE EVENT AND THE CUSTOMER WAS ADVISED TO CONSIDER CHANGING INSULIN, RESERVOIR AND INFUSION SET. TROUBLESHOOTING WAS PERFORMED FOR THE BLANK DISPLAY AND COSMETIC DAMAGE AND THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED AND INSTRUCTED TO REVERT TO A BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS AND PLACE PUMP IN STORAGE MODE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE INSULIN PUMP. MMT-1885 WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THAT THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579978 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885 HG630APZZ

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown