BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 23206725 · Received October 3, 2025

    Report

    Report Number
    2032227-2025-274497
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    September 12, 2025
    Report Date
    February 4, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    003

    Narratives

    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 .08800 INCHES. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM NOTED. THE PUMP WAS MONITORED, NO KEYPAD ANOMALY, UNEXPECTED BATTERY POWER LOSS AND PUMP ERROR 43 ALARM NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. ON THE PRIMARY SVN#: (B)(4) EVENT DATE OF 12-SEP-2025, THERE IS NO UNEXPECTED ALARM(S)/SUSPENDS RECORDED IN THE FORMATTED HISTORY FILE. ON THE PRIMARY SVN#: (B)(4) EVENT DATE OF 12-SEP-2025 OF THE DAILYTOTALCOLLECTIONSTARTTIME, THE DAILYTOTALOFBASALINSULINDELIVERED = 237000 (23.7 U) AND DAILYTOTALOFBOLUSINSULINDELIVERED = 120750 (12.075 U) WHICH IS EQUAL TO THE DAILYTOTALOFALLINSULINDELIVERED = 357750 (35.775 U). ALL BOLUS/BASAL WERE DELIVERED IN AUTO MODE/MANUAL MODE. 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 FOUND ON: 09/09/2025 15:01:32.000. 09/12/2025 17:44:54.000. 09/12/2025 18:02:18.000, 09/12/2025 18:12:00.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: 09/09/2025 14:59:26.000. 09/09/2025 15:00:51.000. PUMP ERROR 23 ALARM WAS FOUND ON: 09/12/2025 18:13:04.000. POWER LOSS ALARM WAS FOUND ON: 09/12/2025 18:13:24.000. 09/12/2025 18:13:32.000. 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 10-SEP-2025 AT 16:24:59.000. THERE WAS NO POWER DATA AVAILABLE FOR THE RELATED SVN#: (B)(4) EVENT DATE OF 09-SEP-2025. UNABLE TO CHECK POWER DATA FOR FAILED BATTERY ALERT/BATTERY FAILED ALARM. PUMP ERROR 23 ALARM AND POWER LOSS ALARM WERE EXPECTED SINCE THE PUMP RESETS AFTER THE BATTERY WAS REMOVED FOR MORE THAN 10 MINUTES. NO UNEXPECTED FAILED BATTERY ALERT/BATTERY FAILED ALARM, PUMP ERROR 23 ALARM AND POWER LOSS ALARM NOTED DURING TESTING. IN FURTHER CHECKING OF THE PUMP HISTORY RECORDS: BATTERY CYCLE 1 RECEIVED THE LOWBATTERYALERT (104) ON 08/25/2025 11:21:00 AFTER MORE THAN 7 DAYS AT 19.61 DAYS. BATTERY CYCLE 2 RECEIVED THE LOWBATTERYALERT (104) ON 08/05/2025 20:14:00 AFTER MORE THAN 7 DAYS AT 13.43 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, THERE WERE NO UNEXPECTED PUMP ERROR(S)/ALARM(S) NOTED 2 DAYS PRIOR TO THE RELATED SVN#: (B)(4) EVENT DATE OF 21-AUG-2025. THERE WAS ¿NO¿ NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM RECORDED IN THE FORMATTED HISTORY FILE. NO UNEXPECTED NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM NOTED DURING TESTING. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK PRIOR TO THE PRIMARY SVN#: (B)(4) EVENT DATE OF 12-SEP-2025 AND RELATED SVN#: (B)(4) EVENT DATE OF 09-SEP-2025, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: LOSTSENSOR1ALERT (780) WAS FOUND ON: 09/03/2025 03:02:00.000 TO 09/12/2025 13:57:00.000 LOSTSENSOR2ALERT (781) WAS FOUND ON: 09/08/2025 10:32:00.000. 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. PUMP ERROR 43 ALARM WAS FOUND ON: 09/12/2025 18:12:00.000. ALL BUTTONS FUNCTION PROPERLY. THE KEYPAD OVERLAY WAS REMOVED TO PERFORM VISUAL INSPECTION AND NO DAMAGE IN THE KEYPAD ASSEMBLY NOTED. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND THE J1 CONNECTOR ON PCBA 1 WAS LOCKED PROPERLY. 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 (23.83 MV). PUMP ERROR 43 ALARM WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE, SUSPECTED ON HW. THE PUMP WAS RECEIVED WITHOUT A BATTERY. THE PUMP WAS RECEIVED WITHOUT A BATTERY CAP. THE MOLDING KNIT LINE DAMAGE (NEAR THE BELT CLIP PLATE) WAS ACCEPTABLE PER CASE ASSEMBLY COSMETIC SPECIFICATION, (B)(4). THE TEST SC1 CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS. CUSTOMER RETURNED PUMP FOR AN ALLEGED KEYPAD ANOMALY, UNEXPECTED BATTERY POWER LOSS AND NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WERE NOT CONFIRMED. HOWEVER, PUMP ERROR 43 ALARM WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE, SUSPECTED ON HW. 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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. 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 REPORTED THE MID BUTTON HAD TOTALLY STOPPED RESPONDING. THE CUSTOMER REPORTED A BLOOD GLUCOSE VALUE OF 14.8 MMOL/L. THE CUSTOMER EXPERIENCED HYPERGLYCEMIA AND WAS TREATED WITH A MANUAL INJECTION AND AN EMERGENCY ROOM VISIT. THE EVENT INVOLVED PRODUCT(S) MMT-1885. TROUBLESHOOTING WAS PERFORMED FOR THE KEYPAD ANOMALY, AND THE CUSTOMER STATES THAT THE BUTTONS ARE NOT RESPONDING. TROUBLESHOOTING WAS PERFORMED FOR THE HIGH BLOOD GLUCOSE. THE CUSTOMER WAS USING THE PUMP WITHIN 48 HOURS AT THE TIME OF THE EVENT, AND THE AUTO MODE FEATURE WAS ACTIVE AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-1885.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292415 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 NG3336668H

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Unknown