BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 24466514 · Received February 27, 2026

    Report

    Report Number
    2032227-2026-136025
    Event Type
    Injury
    Date Received
    February 27, 2026
    Date of Event
    February 6, 2026
    Report Date
    March 30, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    0000763000960032
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. 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 .08750 INCHES. THE PUMP WAS MONITORED FOR SEVERAL DAYS, 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) 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 EVENT DATE (B)(6) 2026 LISTED ON SMARTSOLVE DUE TO INSUFFICIENT DATA IN THE TRACE/HISTORY FILES. THE PUMP SUCCESSFULLY DELIVERED A 10 UNITS BOLUS DURING THE DISPLACEMENT TEST AND A 25 UNITS BOLUS DURING THE DAT. ALL BOLUSES WERE PROPERLY RECORDED IN THE DAILY HISTORY. NO BOLUS DELIVERY ANOMALY OR HISTORY ANOMALY NOTED. NO UNDER DELIVERY ANOMALY OR OVER DELIVERY ANOMALY NOTED. 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: (B)(6) 2026 12:19:47.000, (B)(6) 2026 23:02:24.000, (B)(6) 2026 23:12:00.000. LOW BATTERY ALERT WAS FOUND ON: (B)(6) 2026 20:54:00.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: (B)(6) 2026 08:37:26.000, (B)(6) 2026 08:47:00.000, (B)(6) 2026 09:31:06.000, (B)(6) 2026 09:41:01.000, (B)(6) 2026 12:13:14.000, REPLACE BATTERY ALERT WAS FOUND ON: (B)(6) 2026 06:25:00.000, (B)(6) 2026 06:35:00.000. REPLACE BATTERY NOW ALARM WAS FOUND ON: (B)(6) 2026 06:56:00.000, (B)(6) 2026 07:06:00.000. POWER LOSS ALARM WAS FOUND ON: (B)(6) 2026 12:20:14.000, (B)(6) 2026 23:13:28.000, (B)(6) 2026 23:13:36.000. PUMP ERROR 23 ALARM WAS FOUND ON: (B)(6) 2026 23:13:05.000. 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) 2026 AT 13:14:59.000. THERE WAS NO POWER DATA AVAILABLE FOR THE DATES OF (B)(6) 2026. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT, FAILED BATTERY ALERT/BATTERY FAILED ALARM, REPLACE BATTERY ALERT, REPLACE BATTERY NOW ALARM, POWER LOSS ALARM AND PUMP ERROR 23 ALARM. NO UNEXPECTED LOW BATTERY ALERT, FAILED BATTERY ALERT/BATTERY FAILED ALARM, REPLACE BATTERY ALERT, REPLACE BATTERY NOW ALARM, POWER LOSS ALARM AND PUMP ERROR 23 ALARM NOTED DURING TESTING. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK PRIOR TO THE EVENT DATE OF (B)(6) 2026, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: LOSTSENSOR1ALERT (780) WAS FOUND ON: (B)(6) 2026 04:50:00.000, (B)(6) 2026 05:00:00.000, (B)(6) 2026 02:05:00.000, (B)(6) 2026 02:15:00.000, (B)(6) 2026 03:15:00.000, (B)(6) 2026 19:20:00.000, (B)(6) 2026 20:28:00.000, (B)(6) 2026 20:38:00.000. SENSORERRORALERT (801) WAS FOUND ON: (B)(6) 2026 05:08:54.000, (B)(6) 2026 05:18:00.000, (B)(6) 2026 13:59:11.000, (B)(6) 2026 14:09:00.000, (B)(6) 2026 23:37:59.000. SENSOREXPIREDALERT (794) WAS FOUND ON: (B)(6) 2026 18:49:11.000, (B)(6) 2026 18:59:00.000, (B)(6) 2026 19:29:10.000, (B)(6) 2026 21:38:34.000. THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (4) TRANSMITTER AND A GLUCOSE SENSOR SIMULATOR. THE PUMP CONNECTED SUCCESSFULLY TO THE TRANSMITTER AND DISPLAYED ¿TRANSMITTER CONNECTION SUCCESSFUL¿. NO LOST SENSOR ALERT, SENSOR ERROR ALERT, SENSOR EXPIRED 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 (23.30 MV). THE PUMP WAS RECEIVED WITHOUT A BATTERY. THE PUMP WAS RECEIVED WITH A BATTERY CAP. NO CRACKED/DAMAGED BATTERY CAP NOTED DURING VISUAL INSPECTION. 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/DKA. CUSTOMER ALLEGED FOR BLANK DISPLAY AND POSSIBLE UNDER DELIVERY ANOMALY WERE 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 ALLEGES THE PUMP WAS NO LONGER DELIVERING INSULIN CORRECTLY, AND HAD THE BLANK DISPLAY. THE CUSTOMER REPORTED A BLOOD GLUCOSE VALUE OF 400 MG/DL. THE CUSTOMER EXPERIENCED HYPERGLYCEMIA, AND WAS TREATED WITH A MANUAL INJECTION. THE CUSTOMER EXPERIENCED HYPERGLYCEMIA, DIABETIC KETOACIDOSIS AND WAS TREATED WITH AN IV INSULIN DRIP (INTRAVENOUS INSULIN INFUSION), HOSPITALIZATION: OVERNIGHT STAY, AS WELL AS SELF-TREATMENT OF A SEVERE GLYCEMIC EXCURSION OF MAJOR SEVERITY. THE CUSTOMER HAD BLOOD GLUCOSE LEVELS THAT REMAINED HIGH FOR MORE THAN FOUR HOURS. THERE WAS MENTION OF SYMPTOMS LIKE THROWING UP , NAUSEA. THE EVENT INVOLVED PRODUCT(S) UNOMEDICAL,UNK_RESERVOIR,MMT-1884, AND UNK_SENSOR. TROUBLESHOOTING WAS PERFORMED FOR THE HIGH BLOOD GLUCOSE. IT WAS UNKNOWN WHETHER THE CUSTOMER WAS USING THE PUMP WITHIN 48 HOURS BEFORE THE EVENT AND WHETHER THE AUTO MODE FEATURE WAS ACTIVE OR NOT AT THE TIME OF THE EVENT. TROUBLESHOOTING WAS PERFORMED FOR THE BLANK DISPLAY, AND THE CUSTOMER REPORTED AN ISSUE WITH THE PUMP DISPLAY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR UNOMEDICAL,UNK_RESERVOIR, AND UNK_SENSOR. THE CUSTOMER WAS INSTRUCTED TO DISCONTINUE DEVICE USE. MMT-1884 WAS REQUESTED, AND THE CUSTOMER'S RESPONSE WAS THAT THE DEVICE WOULD BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532601 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 NG4167404H 0000763000960032

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention| H FRN-UNK-RSVR, UNOMED SET, MDS-UNK_SENSOR.