BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 24332934 · Received February 13, 2026

    Report

    Report Number
    2032227-2026-126774
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    January 23, 2026
    Report Date
    March 31, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000734435
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE FUNCTIONAL TEST, 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 THE DAT AT 0.0871 INCHES. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, SCRATCHED KEYPAD OVERLAY AND PILLOWING KEYPAD OVERLAY. THE SC1 CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP AND CARELINK UPLOAD WAS SUCCESSFUL. THE PUMP WAS RECEIVED WITHOUT A BATTERY. THE PUMP WAS RECEIVED WITHOUT THE BATTERY CAP. ON THE EVENT DATE OF (B)(6) 2026 OF THE DAILYTOTALCOLLECTIONSTARTTIME, THE DAILYTOTALOFBASALINSULINDELIVERED = 156750 (15.675 U) AND DAILYTOTALOFBOLUSINSULINDELIVERED = 131250 (13.125 U) WHICH IS EQUAL TO THE DAILYTOTALOFALLINSULINDELIVERED = 288000 (28.8 U). PERFORM THE HISTORY REVIEW 1 WEEK FROM THE EVENT DATE (B)(6) 2026 IN THE PUMP HISTORY FILE AND FOUND 22 SENSORERRORALERT (801) ON (B)(6) 2026, 1 LOWBATTERYALERT (104) ON (B)(6) 2026 06:16:00.000, 1 CHANGEBATTERYFAULT (73) ON (B)(6) 2026 15:47:00.000, 2 SENSORERRORALERT (801) ON (B)(6) 2026, 1 LOSTSENSOR1ALERT (780) ON (B)(6) 2026, 9 NODELIVERY ALARM ON (B)(6) 2026 (DURING BOLUS/BASAL), 6 SENSORERRORALERT (801) ON (B)(6) 2026, 29 SENSORERRORALERT (801) ON (B)(6) 2026, 27 NODELIVERY ALARM ON (B)(6) 2026 (DURING BOLUS/BASAL), 2 BATTOUTLIMIT (6) ON (B)(6) 2026, 13 SENSORERRORALERT (801) ON (B)(6) 2026, 5 NODELIVERY ALARM ON (B)(6) 2026 (DURING BOLUS), AND 3 LOSTSENSOR1ALERT (780) ON (B)(6) 2026, EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON (B)(6) 2026 9:50:52 AM. 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/CHANGEBATTERYFAULT (73), AND POWER LOSS ALARM/BATTOUTLIMIT (6) ALARM. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. THE PUMP PROPERLY PAIRED WITH THE GUARDIAN LINK 3 TRANSMITTER. AFTER THE PUMP COMPLETED WARM UP AND CALIBRATION, THE PUMP WAS ABLE TO DISPLAY THE TEST BG VALUE OF 13.3 MMOL/L ON THE PUMP'S HOME SCREEN. NO COMMUNICATION ANOMALY, CALIBRATION ANOMALY, SENSOR ERROR ALERT OR LOST SENSOR ALERT NOTED. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.9 MV). THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED HIGH BGS. DELIVERY ANOMALY-NO DELIVERY/OCCLUSION ALARM (INSULIN FLOW BLOCK ALARM) 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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED INSIDE THE UNITED STATES. 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. THE CUSTOMER ALSO REPORTED INSULIN FLOW BLOCKED ALARM. BLOOD GLUCOSE VALUE AT THE TIME OF EVENT WAS 22 MMOL/L. THE CUSTOMER WAS TREATED WITH INSULIN PUMP (SUBCUTANEOUS INSULIN INFUSION). THE EVENT INVOLVED PRODUCT(S) MMT-1885. TROUBLESHOOTING WAS PERFORMED AND PUMP PASSED 5U FILL CANNULA TEST. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-1885.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397430 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885 NG3832013H 000000763000734435

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown