BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 24360842 · Received February 16, 2026

    Report

    Report Number
    2032227-2026-128310
    Event Type
    Injury
    Date Received
    February 16, 2026
    Date of Event
    January 27, 2026
    Report Date
    March 11, 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
    NC, 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 .08715 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 PRIMED PROPERLY. THE PUMP WAS MONITORED, NO PUMP ERROR 37 ALARM NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. ON THE EVENT DATE OF 27-JAN-2026, THERE IS NO UNEXPECTED ALARM(S)/SUSPENDS RECORDED IN THE FORMATTED HISTORY FILE. HOWEVER, NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS NOTED. UNABLE TO VERIFY DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE 27-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 EVENT DATE OF 27-JAN-2026, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: MULTIPLE NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WERE FOUND ON 23-JAN-2026 AND 27-JAN-2026 DURING BOLUS/BASAL DELIVERIES. NO UNEXPECTED NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM NOTED DURING TESTING. LOW BATTERY ALERT WAS FOUND ON: 01/25/2026 08:00:00.000. INSERT BATTERY ALARM WAS FOUND ON: 01/25/2026 17:34:46.000, 01/27/2026 05:21:12.000, 01/27/2026 08:37:38.000, 01/27/2026 08:40:58.000, 01/27/2026 08:50:00.000. REPLACE BATTERY ALERT WAS FOUND ON: 01/25/2026 17:31:00.000. POWER LOSS ALARM WAS FOUND ON: 01/27/2026 08:58:48.000. PUMP ERROR 23 ALARM WAS FOUND ON: 01/28/2026 19:20:15.000. 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 26-JAN-2026 AT 12:25:56.000. THERE WAS NO POWER DATA AVAILABLE FOR THE DATE OF 25-JAN-2026. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT AND REPLACE BATTERY ALERT. POWER LOSS ALARM WAS EXPECTED SINCE THE PUMP RESETS AFTER THE BATTERY WAS REMOVED FOR MORE THAN 10 MINUTES. UPON CHECKING THE DETAILED TRACE FILE/DIAGNOSTIC TRACE FILE, PUMP ERROR 23 ALARM WAS EXPECTED. THE BEHAVIOR WAS EXPECTED SINCE THE USER REMOVED AA BATTERY AND PRESSED BACK KEY FOR > 8 SEC - THIS DISCONNECTS BACKUP BATTERY AND PUMP LOOSES POWER. NO UNEXPECTED LOW BATTERY ALERT, REPLACE BATTERY ALERT, POWER LOSS ALARM AND PUMP ERROR 23 ALARM NOTED DURING TESTING. LOSTSENSOR1ALERT (780) WAS FOUND ON: 01/21/2026 07:06:00.000, 01/21/2026 12:06:00.000, 01/26/2026 12:50:00.000, 01/26/2026 21:20:00.000, 01/26/2026 22:20:00.000. SGCALIBRATIONERROR (776) WAS FOUND ON: 01/26/2026 00:23:05.000. LOSTSENSOR2ALERT (781) WAS FOUND ON: 01/26/2026 21:37:00.000. 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, SG CALIBRATION ERROR OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. PUMP ERROR 37 ALARM WAS FOUND ON: 01/28/2026 18:59:03.000. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND SLIGHT CORROSION ON THE PCBA 1 AND PCBA 2. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.17 MV). PUMP ERROR 37 ALARM WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE, PROBLEM ISOLATED ON THE MOTOR ASSEMBLY NOTED. 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. CUSTOMER ALLEGED FOR NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM AND PRIME/FILL ANOMALY WERE NOT CONFIRMED. HOWEVER, PUMP ERROR 37 ALARM WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE, PROBLEM ISOLATED ON THE MOTOR ASSEMBLY NOTED. DURING VISUAL INSPECTION, SLIGHT CORROSION WAS FOUND ON THE PCBA 1, AND PCBA 2. 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 WITH INSULIN FLOW BLOCK ALARM. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 473 MG/DL. THE CUSTOMER WAS TREATED WITH INJECTION AND VISITED EMERGENCY ROOM. THE EVENT INVOLVED PRODUCT(S) UNOMEDICAL, MMT-1884, MMT-332A, UNK-SENSOR. TROUBLESHOOTING WAS PARTIALLY PERFORMED. IT WAS UNKNOWN WHETHER THE CUSTOMER WAS USING THE AUTO MODE/SMARTGUARD FEATURE AT THE TIME OF THE EVENT OR NOT AND THE CUSTOMER HAS BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT OR NOT. CUSTOMER REPORTED BEING UNABLE TO EXIT LOAD RESERVOIR PROCESS, ATTEMPTED TO COMPLETE AGAIN BUT PUMP COULD NOT COMPLETE THE LOAD RESERVOIR PROCESS. THE PAST INSULIN BLOCK EVENT WAS RESOLVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. CUSTOMER WILL DISCONTINUE TO USE THE INSULIN PUMP. MMT-1884 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. NO RETURN IS RERQUIRED FOR UNOMEDICAL, MMT-1884, MMT-332A, UNK-SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442546 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 NG4081657H

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Required Intervention FRN-MMT-332A-RSVR, UNOMED SET, OZP-UNK-SNSR.