BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 22491344 · Received July 14, 2025

    Report

    Report Number
    2032227-2025-211216
    Event Type
    Death
    Date Received
    July 14, 2025
    Date of Event
    June 13, 2025
    Report Date
    August 11, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000924089
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 .08785 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. ON THE SS EVENT DATE OF 13-JUN-2025, THERE IS NO UNEXPECTED ALARMS/SUSPENDS RECORDED IN THE FORMATTED HISTORY FILE. ON THE SAP NOTE EVENT DATE OF 15-JUN-2025, THERE IS AUTOSUSPEND (12) RECORDED IN THE FORMATTED HISTORY FILE ON (B)(6) 2025 05:01:00.000 AND (B)(6) 2025 05:11:00.000. UPON CHECKING THE PUMP DIAGNOSTIC TRACE FILE, AUTO SUSPEND ALARM WAS EXPECTED SINCE NO KEYS PRESSED IN THE TIME DURATION SET (12 HOURS) FOR AUTO SUSPEND. UNABLE TO VERIFY DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE SS EVENT DATE OF 13-JUN-2025 AND SAP NOTE EVENT DATE OF 15-JUN-2025 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 SS EVENT DATE OF 13-JUN-2025 AND SAP NOTE EVENT DATE OF 15-JUN-2025, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: LOSTSENSOR1ALERT (780) WAS FOUND ON: (B)(6) 2025 03:24:00.000. (B)(6) 2025 04:01:00.000, (B)(6) 2025 04:11:00.000. (B)(6) 2025 22:00:00.000. (B)(6) 2025 20:22:00.000, (B)(6) 2025 20:32:00.000. (B)(6) 2025 10:25:00.000, (B)(6) 2025 10:35:00.000. (B)(6) 2025 16:58:00.000, (B)(6) 2025 17:08:00.000. LOSTSENSOR2ALERT (781) WAS FOUND ON: (B)(6) 2025 10:51:00.000. (B)(6) 2025 10:51:00.000. (B)(6) 2025 18:55:00.000. 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 OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. INSERT BATTERY ALARM WAS FOUND ON: (B)(6) 2025 19:27:46.000 (B)(6) 2025 12:14:40.000 (B)(6) 2025 07:52:35.000 (B)(6) 2025 08:03:00.000, (B)(6) 2025 08:27:18.000 (B)(6) 2025 08:37:00.000 LOW BATTERY ALERT WAS FOUND ON: (B)(6) 2025 09:44:00.000 REPLACE BATTERY ALERT WAS FOUND ON: (B)(6) 2025 09:44:00.000 (B)(6) 2025 19:25:00.000 PUMP ERROR 23 ALARM WAS FOUND ON: (B)(6) 2025 08:03:05.000 (B)(6) 2025 08:38:04.000 POWER LOSS ALARM WAS FOUND ON: (B)(6) 2025 08:03:21.000, (B)(6) 2025 08:03:29.000 (B)(6) 2025 08:38:14.000, (B)(6) 2025 08:38:22.000 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 (B)(6) 2025 AT 15:21:59.000. THERE WAS NO POWER DATA AVAILABLE FOR THE EVENT DATE OF 08-JUN-2025. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT AND REPLACE BATTERY ALERT. PUMP ERROR 23 ALARM AND POWER LOSS ALARM WERE EXPECTED SINCE THE BATTERY WAS REMOVED FOR MORE THAN 10 MINUTES. NO UNEXPECTED LOW BATTERY ALERT, REPLACE BATTERY ALERT, PUMP ERROR 23 ALARM AND POWER LOSS ALARM 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 (23.32 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 SC1 CAP LOCKS PROPERLY INTO THE RESERVOIR COMPARTMENT. 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.

    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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER PASSED AWAY AT THE HOSPITAL ON (B)(6) 2025. THE CUSTOMER WAS ADMITTED TO A HOSPITAL PRIOR TO THE REPORTED INCIDENT. THE CAUSE OF DEATH WAS HEMORRHAGIC STROKE, NEUROPATHY, SEVERE BACK PAIN AND TYPE 1 DIABETES. THE CUSTOMER¿S BLOOD GLUCOSE WAS 154 MG/DL. THE EVENT INVOLVED PRODUCT(S) MMT-342G, MMT-442AK, MMT-1884. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH AND PUMP WAS WORN AT TIME OF PASSING. THE CUSTOMER WAS USING SENSORS. THE INSULIN PUMP WAS LAST WORN ON UNKNOWN, PRIOR TO PASSING. NO PRODUCT RETURN IS REQUIRED FOR MMT-342G, MMT-442AK. MMT-1884 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792702 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 NG3940948H 000000763000924089

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Death| R| H FRN- MMT-342G-RSVR, UNOMED INF SET