BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 24031237 · Received January 9, 2026

    Report

    Report Number
    2032227-2026-104842
    Event Type
    Injury
    Date Received
    January 9, 2026
    Date of Event
    December 18, 2025
    Report Date
    March 30, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    PMA / PMN Number
    P150001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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 .08730 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. ON THE EVENT DATE OF 14-DEC-2025, THERE IS NO UNEXPECTED ALARM(S)/SUSPENDS RECORDED IN THE FORMATTED HISTORY FILE. HOWEVER, NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS NOTED. ON THE EVENT DATE OF 14-DEC-2025 OF THE DAILYTOTALCOLLECTIONSTARTTIME, THE DAILYTOTALOFBASALINSULINDELIVERED = 85750 (8.575 U) AND DAILYTOTALOFBOLUSINSULINDELIVERED = 7000 (0.7 U) WHICH IS EQUAL TO THE DAILYTOTALOFALLINSULINDELIVERED = 92750 (9.275 U). ALL BOLUS/BASAL WERE DELIVERED IN AUTO MODE/MANUAL MODE. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK FROM THE EVENT DATE OF 14-DEC-2025, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: MULTIPLE NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WERE FOUND ON (B)(6) 2025 DURING BOLUS/BASAL/PRIME DELIVERIES. 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 DURING TESTING. LOW BATTERY ALERT WAS FOUND ON: (B)(6) 2025 05:02:01.000, REPLACE BATTERY ALERT WAS FOUND ON: (B)(6) 2025 14:33:00.000, REPLACE BATTERY NOW ALARM WAS FOUND ON: (B)(6) 2025 15:04:00.000, (B)(6) 2025 15:14:00.000, PUMP ERROR 23 ALARM WAS FOUND ON: (B)(6) 2025 15:15:03.000 POWER LOSS ALARM WAS FOUND ON: (B)(6) 2025 15:15:23.000, (B)(6) 2025 15:15:31.000. 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. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, LOW BATTERY ALERT, REPLACE BATTERY ALERT, REPLACE BATTERY NOW ALARM 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 SINCE THE PUMP RESET DUE TO BATTERY BACKUP DEPLETION. NO UNEXPECTED LOW BATTERY ALERT, REPLACE BATTERY ALERT, REPLACE BATTERY NOW ALARM, PUMP ERROR 23 ALARM AND POWER LOSS ALARM NOTED DURING TESTING. LOSTSENSOR1ALERT (780) WAS FOUND ON: (B)(6) 2025 17:27:00.000. LOSTSENSOR2ALERT (781) WAS FOUND ON: (B)(6) 2025 17:44:00.000. SENSOREXPIREDALERT (794) WAS FOUND ON: (B)(6) 2025 16:51:31.000. 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, 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 (24.34 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 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 STAINED 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 BROKEN BELT CLIP RAILS. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS/DKA. 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. 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 HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 840 MG/DL. THE CUSTOMER WAS HOSPITALIZED, WHERE HYPERGLYCEMIA WAS TREATED WITH AN INTRAVENOUS (IV) INSULIN DRIP. KETONE TESTING WAS PERFORMED, AND RESULTS WERE CONSISTENT WITH HYPERGLYCEMIA, AND THIS WAS ALSO TREATED WITH AN INTRAVENOUS (IV) INSULIN DRIP. THE CUSTOMER REPORTED SYMPTOMS INCLUDING FEELING SICK/UNWELL AND BAD COLD. THE EVENT INVOLVED PRODUCT(S) MMT-1880, MMT-7911NA, MMT-332A, MMT-7040MA, MMT-396A. TROUBLESHOOTING WAS PERFORMED. THE STARTED A REWIND ON THE PUMP AND DID NOT COMPLETE IT. THE CUSTOMER WAS USING THE INSULIN PUMP WITHIN 48 HOURS OF THE REPORTED EVENT. THE AUTO MODE FEATURE WAS NOT ACTIVE AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-1880, MMT-7911NA, MMT-332A, MMT-7040MA, MMT-396A. FRN-MMT-332A-RSVR, UNOMED INF SET, OZP-MMT-7040MA-SNSR, PQF-MMT-7911NA-XMTR

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92385 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 HG625B6ZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention| H RESERVOIR (FRN) / INFUSION SET (FPA)