BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 24341782 · Received February 16, 2026

    Report

    Report Number
    2032227-2026-127470
    Event Type
    Injury
    Date Received
    February 16, 2026
    Date of Event
    January 17, 2026
    Report Date
    March 16, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 PRIMARY SVN#: (B)(4) AND RELATED SVN#: (B)(4) WITH THE SAME EVENT DATE OF 17-JAN-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)(4) AND RELATED SVN#: (B)(4) WITH THE SAME EVENT DATE OF 17-JAN-2026, LISTED ON SMARTSOLVE DUE TO INSUFFICIENT DATA IN THE TRACE/HISTORY FILES. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK PRIOR TO THE PRIMARY SVN#: (B)(4) AND RELATED SVN#: (B)(4) WITH THE SAME EVENT DATE OF 17-JAN-2026, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: MULTIPLE NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WERE FOUND ON (B)(6) 2026 AND (B)(6) 2026 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) 2026 15:46:00.000. REPLACE BATTERY ALERT WAS FOUND ON: (B)(6) 2026 01:17:00.000. REPLACE BATTERY NOW ALARM WAS FOUND ON: (B)(6) 2026 01:48:00.000, (B)(6) 2026 01:58:00.000. PUMP ERROR 23 ALARM WAS FOUND ON: (B)(6) 2026 01:59:04.000. POWER LOSS ALARM WAS FOUND ON: (B)(6) 2026 01:59:33.000, (B)(6) 2026 01:59:41.000. 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. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON (B)(6) 2026 AT 08:08:57.000. THERE WAS NO POWER DATA AVAILABLE FOR THE DATES OF (B)(6) 2026 AND (B)(6) 2026. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT, REPLACE BATTERY ALERT, REPLACE BATTERY NOW ALARM, PUMP ERROR 23 ALARM AND POWER LOSS ALARM. NO UNEXPECTED LOW BATTERY ALERT, REPLACE BATTERY ALERT, REPLACE BATTERY NOW ALARM, PUMP ERROR 23 ALARM AND POWER LOSS ALARM NOTED DURING TESTING. SENSORERRORALERT (801) WAS FOUND ON: (B)(6) 2026 18:24:46.000, (B)(6) 2026 02:24:47.000, (B)(6) 2026 02:34:00.000. 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 SENSOR ERROR 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 (23.36 MV). THE PUMP WAS RECEIVED WITHOUT A BATTERY. THE PUMP WAS RECEIVED WITH A BATTERY CAP WITH A BROKEN 2 HEAT STAKE POST. 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 CRACKED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY AND A SCRATCHED CASE. 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. 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 EXPERIENCED HYPERGLYCEMIA AND ELEVATED KETONES/DIABETIC KETOACIDOSIS. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 600 MG/DL. THE CUSTOMER WAS HOSPITALIZED AND TREATED WITH INSULIN PUMP AND INSULIN PEN FOR HYPERGLYCEMIA. THE REPORTED ELEVATED KETONES/DIABETIC KETOACIDOSIS WAS TREATED BY HOSPITALIZATION. SYMPTOMS WITNESSED AT THE TIME OF HOSPITALIZATION: VOMITING, CONFUSION, FEELING SICK/UNWELL AND HEADACHE. THE EVENT INVOLVED PRODUCTS MMT-1884, MMT-7040A, MMT-874 AND MMT-332A. TROUBLESHOOTING WAS PARTIALLY PERFORMED FOR HIGH BLOOD GLUCOSE WHICH HAS OCCURRED FOR MORE THAN 4 HOURS. THE CUSTOMER HAS USED THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT. THE CUSTOMER USED THE SMARTGUARD/AUTO MODE OF THE INSULIN PUMP AT THE TIME OF REPORTED 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. MMT-1884 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. NO PRODUCT RETURN IS REQUIRED FOR MMT-7040A. NO PRODUCT RETURN IS REQUIRED FOR MMT-874. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371 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 NG3239044H

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention| H FRN-MMT-332A-RSVR, UNOMED SET, OZP-MMT-7040A-SNSR.