BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 24528333 · Received March 6, 2026

    Report

    Report Number
    2032227-2026-139905
    Event Type
    Injury
    Date Received
    March 6, 2026
    Date of Event
    February 17, 2026
    Report Date
    April 3, 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
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER RETURNED PUMP FOR AN ALLEGED PUMP/TRANSMITTER COMMUNICATION ANOMALY, POSSIBLE OVER DELIVERY ANOMALY AND VISIT TO EMERGENCY ROOM FOR HIGH BGS/LOW BGS FOUND ON (B)(6) 2026 (PER SS EVENT DATE). ON RELATED SVN #: (B)(6) - CUSTOMER RETURNED PUMP FOR AN ALLEGED POSSIBLE OVER DELIVERY ANOMALY, EXPOSURE TO MAGNETIC FIELD OR MRI AND VISIT TO EMERGENCY ROOM FOR HIGH BGS/LOW BGS FOUND ON (B)(6) 2026. 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 .08705 INCHES. NO UNEXPECTED PUMP ERROR 37, 38, OR 130 ALARMS, INSULIN FLOW BLOCKED ALARMS, OR DISPLACEMENT ANOMALIES NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. ON THE PRIMARY SVN #: (B)(6) EVENT DATE OF 17-FEB-2026 AND RELATED SVN #: (B)(6) EVENT DATE OF 18-FEB-2026, THERE WERE 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)(6) EVENT DATE OF 17-FEB-2026 AND RELATED SVN #: (B)(6) EVENT DATE OF 18-FEB-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. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK FROM THE PRIMARY SVN #: (B)(6) EVENT DATE OF 17-FEB-2026 AND RELATED SVN#: (B)(6) EVENT DATE OF 18-FEB-2026, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: INSERT BATTERY ALARM WAS FOUND ON: 02/18/2026 20:59:08.000 PUMP ERROR 23 ALARM WAS FOUND ON: 02/18/2026 21:00:10.000 PUMP ERROR 68 ALARM WAS FOUND ON: 02/18/2026 20:59:38.000 PUMP ERROR 49 ALARM WAS FOUND ON: 02/18/2026 20:59:38.000 02/18/2026 20:59:52.000 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. PUMP ERROR 68 ALARM, PUMP ERROR 49 ALARM AND PUMP ERROR 23 ALARM WERE EXPECTED SINCE THE PUMP RESTARTED AFTER PUMP SHUTDOWN. NO UNEXPECTED PUMP ERROR 68 ALARM, PUMP ERROR 49 ALARM AND PUMP ERROR 23 ALARM NOTE DURING TESTING. LOSTSENSOR1ALERT (780) WAS FOUND ON: 02/17/2026 18:22:00.000 SENSOR ERROR ALERT (801) WAS FOUND ON: 02/17/2026 03:07:03.000 SG CALIBRATION ERROR (776) WAS FOUND ON: 02/18/2026 13:42:32.000 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, SG CALIBRATION ERROR 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 (22.87 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 SCRATCHED CASE. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS/LOW BGS. CUSTOMER ALLEGED FOR PUMP/TRANSMITTER COMMUNICATION ANOMALY, POSSIBLE OVER DELIVERY ANOMALY AND EXPOSURE TO MAGNETIC FIELD OR MRI 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 EXPERIENCED HYPOGLYCEMIA AND HYPERGLYCEMIA. THE CUSTOMER REPORTED INSULIN OVER DELIVERY, PUMP EXPOSED WITH MAGNETIC FIELD, COMMUNICATION ISSUE BETWEEN PUMP AND SENSOR. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 35 MG/DL. THE CUSTOMER REPORTED HYPOGLYCEMIA TREATED WITH GLUCOSE/CARB INTAKE, HAD AN EMERGENCY VISIT TO HOSPITAL. THE EVENT INVOLVED PRODUCT(S) MMT-1884, MMT-342, MMT-431AK, 78893-01. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS USING THE PUMP FOR 48 HOUR BEFORE THE REPORTED EVENT. THE CUSTOMER WAS USING THE AUTO MODE/SMARTGUARD FEATURE AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR 78893-01. MMT-1884, MMT-342, MMT-431AK WERE REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. THE CUSTOMER WILL DISCONTINUE USING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592952 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 NG3804629H

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention FRN-MMT-342-RSVR, UNOMED INF SET, QBJ-78893-01-SNS