BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 23712549 · Received December 4, 2025

    Report

    Report Number
    2032227-2025-311799
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    November 7, 2025
    Report Date
    January 16, 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
    KY, 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 .08750 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. ON THE EVENT DATE OF 07-NOV-2025, 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 07-NOV-2025 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. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK PRIOR TO THE EVENT DATE OF 07-NOV-2025, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: LOSTSENSOR1ALERT (780) WAS FOUND ON: 11/01/2025 08:32:00.000. 11/03/2025 19:27:00.000. 11/04/2025 07:03:00.000. 11/06/2025 05:57:00.000. SENSORERRORALERT (801) WAS FOUND ON: 11/03/2025 17:21:04.000. 11/06/2025 20:16:34.000. LOSTSENSOR2ALERT (781) WAS FOUND ON: 11/03/2025 19:45:00.000 THE PUMP WAS PROGRAMMED WITH BASAL PROFILES AND MONITORED. ALL BASAL PROFILES DELIVERED THEIR INDICATED AMOUNTS AND WERE VERIFIED IN THE DAILY AND SUMMARY HISTORY SCREENS. THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (3) TRANSMITTER AND A 240 MG/DL GLUCOSE SENSOR SIMULATOR. THE PUMP WAS THEN PROGRAMMED FOR AUTO MODE. THE DISPLAY SHOWED THE CALIBRATE YOUR SENSOR ALARM PROPERLY AFTER COMPLETION OF THE AUTO MODE WARM UP. THE PUMP SENSOR FEATURE AND THE AUTO MODE CONNECTION ARE WORKING PROPERLY. NO LOST SENSOR ALERT, SENSOR ERROR ALERT OR SENSOR RELATED ERRORS OR ANOMALIES WERE NOTED. NO AUTO MODE ANOMALY, HISTORY ANOMALY, DELIVERY ANOMALY, BOLUS ANOMALY OR BASAL ANOMALY 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 (23.15 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 LOW BGS. CUSTOMER ALLEGED FOR SMARTGUARD ANOMALY (NO CURRENT CODE/CATEGORY) AND POSSIBLE OVER 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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 PUMP IS OVER DELIVERING. THE CUSTOMER REPORTED A BLOOD GLUCOSE VALUE OF 50 MG/DL. THE CUSTOMER EXPERIENCED HYPOGLYCEMIA AND WAS TREATED WITH GLUCOSE/CARB INTAKE, AND EMERGENCY ROOM VISIT. THE EVENT INVOLVED PRODUCT(S) MMT-7040A, MMT-332A, MMT-1884, AND MMT-397A. TROUBLESHOOTING WAS PERFORMED FOR THE LOW BLOOD GLUCOSE THE CUSTOMER WAS USING THE PUMP WITHIN 48 HOURS AT THE TIME OF THE EVENT, AND THE AUTO MODE FEATURE WAS ACTIVE AT THE TIME OF THE EVENT. TROUBLESHOOTING WAS PERFORMED FOR THE SMARTGUARD BOLUS DELIVERY, AND THE CUSTOMER REPORT AN ADVERSE EVENT AS A RESULT OF REPORTED EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-7040A, MMT-332A, AND MMT-397A. THE CUSTOMER WAS INSTRUCTED TO DISCONTINUE DEVICE USE AND REVERT TO THE BACKUP PLAN WITH THE HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. 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
    1891623 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 NG3983855H

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention FRN-MMT-332A-RSVR, UNOMED SET, OZP-MMT-7040A-SNSR.