BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 25038736 · Received April 30, 2026

    Report

    Report Number
    2032227-2026-168009
    Event Type
    Death
    Date Received
    April 30, 2026
    Date of Event
    April 7, 2026
    Report Date
    April 29, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    QFG
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    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. 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. PLEASE SEE BELOW FOR THE DATE RANGE LISTED IN THE FORMATTED HISTORY FILE. THE FORMATTED HISTORY FILE LISTS DATA FROM (B)(6) 2026 TO (B)(6) 2026. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED ALARM(S)/SUSPENDS AND DAILY TOTAL OF BASAL/BOLUS DELIVERY FOR THE EVENT DATE OF 07-APR-2026. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED PUMP ERROR(S)/ALARM(S) 1 WEEK FROM THE EVENT DATE OF 07-APR-2026 IN THE FORMATTED HISTORY FILE. HOWEVER, IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK PRIOR SURROUNDING THE DATE OF (B)(6) 2026 THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: POWER LOSS ALARM WAS FOUND ON: (B)(6) 2026 17:32:17.000, (B)(6) 2026 17:32:26.000. REPLACE BATTERY ALERT WAS FOUND ON: (B)(6) 2026 16:50:00.000. LOW BATTERY ALERT WAS FOUND ON: (B)(6) 2026 07:19:00.000. REPLACE BATTERY NOW ALARM WAS FOUND ON: (B)(6) 2026 17:21:00.000. PUMP ERROR 23 ALARM WAS FOUND ON: (B)(6) 2026 17:32:05.000. 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. OLD POWER MANAGEMENT TOOL WAS USED AND THERE WAS NO POWER DATA AVAILABLE FOR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM, LOW BATTERY ALERT, PUMP ERROR 23 ALARM AND POWER LOSS ALARM. NO UNEXPECTED REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM, LOW BATTERY ALERT, PUMP ERROR 23 ALARM AND POWER LOSS ALARM NOTED DURING TESTING. LOSTSENSOR1ALERT (780) WAS FOUND ON: (B)(6) 2026 07:07:00.000. LOSTSENSOR2ALERT (781) WAS FOUND ON: (B)(6) 2026 07:34:00.000. 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 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 (23.76 MV). THE PUMP WAS RECEIVED WITH A DEPLETED DURACELL ALKALINE BATTERY INSTALLED. 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. 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 MEDTRONIC MINIMED THAT THE CUSTOMER PASSED AWAY AT HOSPITAL ON (B)(6) 2026. THE CAUSE OF DEATH WAS HEART FAILURE, DIABETES AND DIABETES COMPLICATIONS. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE LAST KNOWN PRODUCT(S) FOR THIS CUSTOMER ARE AS FOLLOWS: MMT-441AJ, MMT-7040A, MMT-342G. THE CUSTOMER WAS USING THE PUMP WITHIN 48 HOURS AT THE TIME OF THE HOSPITALIZATION EVENT. MMT-441AJ, MMT-7040A, MMT-342G, AND 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
    98070 MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1884 NG4002680H

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Other| D FRN-MMT-342G-RSVR, UNOMED SET, OZP-MMT-7040A- SNSR.