BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 22858023 · Received August 21, 2025

    Report

    Report Number
    2032227-2025-241292
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    July 25, 2025
    Report Date
    October 27, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP WAS RECEIVED WITH A KEYPAD OVERLAY PEELING. PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. PUMP PASSED THE DISPLACEMENT TEST, SELF TEST, SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT. PUMP WAS MONITORED, NO BLANK DISPLAY AND RED LED LIGHT/VIBRATING ANOMALY NOTED. SUCCESSFULLY DOWNLOADED PUMP TRACES AND HISTORY FILE USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK PRIOR TO THE EVENT DATE OF 25-JUL-2025, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: PUMP ERROR 4 ALARM WAS FOUND ON: (B)(6) 2025 19:47:31.000. PUMP ERROR 63 ALARM (FILE NUMBER: (B)(4), FILE NUMBER: (B)(4) WAS FOUND ON: (B)(6) 2025 19:47:31.000. PUMP ERROR 63 ALARM (FILE NUMBER: (B)(4), FILE NUMBER: (B)(4) AND PUMP ERROR 4 ALARM WERE CONFIRMED, SUSPECTED ON HW. LOW BATTERY ALERT WAS FOUND ON: (B)(6) 2025 08:41:00.000. REPLACE BATTERY ALERT WAS FOUND ON: (B)(6) 2025 18:12:00.000, ON (B)(6) 2025 18:22:00.000. INSERT BATTERY ALARM WAS FOUND ON: (B)(6) 2025 18:23:50.000, ON (B)(6) 2025 19:52:34.000, ON (B)(6) 2025 19:53:37.000, ON (B)(6) 2025 19:53:54.000. PUMP ERROR 68 ALARM WAS FOUND ON: (B)(6) 2025 19:47:33.000, ON (B)(6) 2025 19:52:50.000, ON (B)(6) 2025 19:53:50.000. PUMP ERROR 49 ALARM WAS FOUND ON: (B)(6) 2025 19:47:33.000, ON (B)(6) 2025 19:52:50.000, ON (B)(6) 2025 19:53:50.000. 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. 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 AND REPLACE 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 68 ALARM AND PUMP ERROR 49 ALARM WERE EXPECTED SINCE THE POWER WAS LOST AND PUMP RESTARTED DUE TO PUMP ERROR 63 ALARM (FILE NUMBER: (B)(4), FILE NUMBER: (B)(4) AND PUMP ERROR 4 ALARM. NO UNEXPECTED LOW BATTERY ALERT, REPLACE BATTERY ALERT, PUMP ERROR 68 ALARM AND PUMP ERROR 49 ALARM NOTED DURING TESTING. LOST SENSOR 1 ALERT (780) WAS FOUND ON: (B)(6) 2025 02:39:00.000, ON (B)(6) 2025 14:19:00.000, ON (B)(6) 2025 16:36:00.000, ON (B)(6) 2025 18:03:00.000, ON (B)(6) 2025 18:13:00.000. LOST SENSOR 2 ALERT (781) WAS FOUND ON: (B)(6) 2025 14:35:00.000, ON (B)(6) 2025 16:53:00.000. 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 WARMUP. 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. 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, PCBA 2 AND FORCE SENSOR. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE 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 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/PEELING. THE PUMP PASSED ALL THE REQUIRED TESTING. COSMETIC DAMAGE WAS CONFIRMED AT THE KEYPAD OVERLAY OF THE PUMP DURING ANALYSIS. CUSTOMER ALLEGED FOR BLANK DISPLAY AND RED LED LIGHT/VIBRATING ANOMALY WERE NOT CONFIRMED. HOWEVER, PUMP ERROR 63 ALARM (FILE NUMBER: (B)(4), FILE NUMBER: (B)(4) AND PUMP ERROR 4 ALARM WERE CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE DUE TO CORROSION ON THE PCBA 1 AND PCBA 2. CORROSION WAS ALSO FOUND ON THE FORCE SENSOR. 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 A BLANK SCREEN, VIBRATING, HAD A RED LED LIGHT, CRACK ON THE FRONT AND NEAR THE BUTTONS. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884. TROUBLESHOOTING WAS PERFORMED FOR DISPLAY ISSUES, AND THE CUSTOMER STATED THAT NO DAMAGE TO THE BATTERY CAP CONTACTS AND BATTERY COMPARTMENT. THE DISPLAY DID NOT RETURN AFTER INSERTING A NEW BATTERY. TROUBLESHOOTING WAS PERFORMED FOR DAMAGE, AND THE CUSTOMER REPORTED DAMAGE TO THE KEYPAD. 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-1884 WAS REQUESTED, AND THE CUSTOMER RESPONDED THAT THE DEVICE WOULD BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2053543 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 NG3867267H

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female