BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 23484733 · Received November 6, 2025

    Report

    Report Number
    2032227-2025-296480
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    October 20, 2025
    Report Date
    January 21, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000545604
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE SELF TEST, ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. THE PUMP WAS MONITORED AND NO UNEXPECTED FAILED BATTERY ALERT/BATTERY FAILED ALARM 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: 10/18/2025 03:48:00.000, 10/18/2025 03:50:00.000. 10/20/2025 13:23:00.000, 10/20/2025 18:48:00.000. INSERT BATTERY ALARM WAS FOUND ON: . 10/18/2025 01:07:20.000 TO 10/18/2025 23:59:03.000. 10/19/2025 14:37:19.000 TO 10/19/2025 17:42:34.000. 10/20/2025 07:49:14.000 TO 10/20/2025 21:34:34.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: 10/18/2025 21:56:14.000 TO 10/18/2025 23:58:51.000. 10/19/2025 14:38:01.000 TO 10/19/2025 17:34:59.000. 10/20/2025 07:49:18.000 TO 10/20/2025 19:09:15.000. PUMP ERROR 23 ALARM WAS FOUND ON: 10/20/2025 19:09:35.000. POWER LOSS ALARM WAS FOUND ON: 10/20/2025 19:09:45.000. 10/20/2025 19:09:53.000. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, FAILED BATTERY ALERT/BATTERY FAILED ALARM AND LOW BATTERY ALERT 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. PUMP ERROR 23 ALARM AND POWER LOSS ALARM WERE EXPECTED. THE BEHAVIOR WAS EXPECTED SINCE THE USER REMOVED AA BATTERY AND PRESSED BACK KEY FOR > 8 SEC - THIS DISCONNECTS BACKUP BATTERY AND PUMP LOOSES POWER. NO UNEXPECTED FAILED BATTERY ALERT/BATTERY FAILED ALARM, LOW BATTERY ALERT, PUMP ERROR 23 ALARM AND POWER LOSS ALARM NOTED DURING TESTING. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE, THERE WERE NO OTHER UNEXPECTED PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE OF 20-OCT-2025. 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. 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 KEYPAD OVERLAY, A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT AND A SERIAL NUMBER LABEL FADING. THE PUMP PASSED ALL THE REQUIRED TESTING. CUSTOMER ALLEGED FOR FAILED BATTERY ALERT/BATTERY FAILED ALARM 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. 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 RECEIVED A BATTERY FAILED ALARM EVEN AFTER REPLACING THE BATTERY. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1880. TROUBLESHOOTING WAS PERFORMED, AND THE CUSTOMER REPORTED DAMAGE TO THE BATTERY CAP OR COMPARTMENT SPRINGS. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND ADVISED TO REVERT TO A BACKUP PLAN PER THE HEALTHCARE PROFESSIONAL'S INSTRUCTIONS AND PLACE THE PUMP IN STORAGE MODE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE INSULIN PUMP. MMT-1880 WAS REQUESTED, AND THE CUSTOMER RESPONDED THAT THE DEVICE WOULD BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2551148 MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880 NG3192591H 000000763000545604

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male