BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 24529860 · Received March 6, 2026

    Report

    Report Number
    2032227-2026-140129
    Event Type
    Injury
    Date Received
    March 6, 2026
    Date of Event
    February 14, 2026
    Report Date
    March 6, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    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. THE PUMP WAS RECEIVED WITH A CRACKED BATTERY TUBE THREADS AND A CRACKED CASE BEHIND THE PUMP 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 .08720 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. ON THE PRIMARY SVN#: (B)(6) WITH EVENT DATE OF 14-FEB-2026, THERE IS NO UNEXPECTED ALARM(S)/SUSPENDS RECORDED IN THE FORMATTED HISTORY FILE. UNABLE TO VERIFY DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE PRIMARY SVN#: (B)(6) WITH EVENT DATE OF 14-FEB-2026 LISTED ON SMARTSOLVE DUE TO INSUFFICIENT DATA IN THE TRACE/HISTORY FILES. PLEASE SEE BELOW FOR THE DATE RANGE LISTED IN THE FORMATTED HISTORY FILE. THE FORMATTED HISTORY FILE LISTS DATA FROM ON (B)(6) 2025 TO ON (B)(6) 2026. THERE WAS NO DATA AVAILABLE TO VERIFY PUMP ERROR(S)/ALARM(S) NOTED 2 DAYS PRIOR TO THE RELATED SVN#: (B)(6) WITH EVENT DATE OF 20-OCT-2025 AND RELATED SVN#: (B)(6) WITH EVENT DATE OF 20-NOV-2025 IN THE FORMATTED HISTORY FILE. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK PRIOR TO THE PRIMARY SVN#: (B)(6) WITH EVENT DATE OF 14-FEB-2026, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: INSERT BATTERY ALARM WAS FOUND ON: (B)(6) 2026 01:57:50.000, ON (B)(6) 2026 02:01:13.000, ON (B)(6) 2026 09:29:07.000, ON (B)(6) 2026 09:39:00.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: (B)(6) 2026 01:58:15.000. PUMP ERROR 23 ALARM WAS FOUND ON: (B)(6) 2026 09:40:04.000. POWER LOSS ALARM WAS FOUND ON: (B)(6) 2026 09:43:24.000, ON (B)(6) 2026 09:43:32.000. 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. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON (B)(6) 2026 AT 14:29:59.000. THERE WAS NO POWER DATA AVAILABLE FOR THE DATE ON (B)(6) 2026. 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. LOST SENSOR 1 ALERT (780) WAS FOUND ON: (B)(6) 2026 00:50:00.000, ON (B)(6) 2026 01:00:00.000. 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. 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 (23.78 MV). THE PUMP WAS RECEIVED WITH A DEPLETED ENERGIZER MAX ALKALINE BATTERY INSTALLED. THE PUMP WAS RECEIVED WITH A BATTERY CAP. NO CRACKED/DAMAGED BATTERY CAP NOTED DURING VISUAL INSPECTION. 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. 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 LOW BGS. CUSTOMER ALLEGED FOR PUMP/TRANSMITTER COMMUNICATION ANOMALY 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED HYPOGLYCEMIA WITH BLOOD GLUCOSE VALUE OF 40 MG/DL. THE CUSTOMER REPORTED HYPOGLYCEMIA WAS TREATED WITH CARBS. THE EVENT INVOLVED PRODUCT(S) MMT-332A, UNOMEDICAL, MMT-1884. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER REPORTED PHYSICAL DAMAGE (CRACK OR SCRATCH) ON THE PUMP NOT RELATED TO THE RETAINER RING. THE CUSTOMER REPORTED A CRACK ON THE BATTERY TUBE SIDE. THE DAMAGE WAS AFFECTING/IMPACTING PUMP FUNCTIONALITY. IT WAS UNKNOWN WHETHER THE CUSTOMER WAS USING THE INSULIN PUMP WITHIN 48 HOURS OF THE REPORTED EVENT. THERE IS NO MENTION OF THE AUTO MODE FEATURE AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE PUMP AND REVERT TO A BACKUP PLAN PER HEALTHCARE PROFESSIONAL INSTRUCTIONS. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A, UNOMEDICAL. MMT-1884 WAS REQUESTED, AND THE CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595518 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 NG3844566H

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other FRN-MMT-332A-RSVR, UNOMED INF SET.