BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 24311026 · Received February 11, 2026

    Report

    Report Number
    2032227-2026-124480
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    January 15, 2026
    Report Date
    April 15, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Removal / Correction Number
    2032227-07-23-2024-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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

    P-CAP LOCKED IN PLACE PROPERLY DURING TESTING. UNIT WAS SUCCESSFULLY DOWNLOADED USING (THUMP SOFTWARE) AND CARELINK. THE ADAPT TOOL WAS UTILIZED TO SEARCH FOR ALARMS THAT MAY HAVE OCCURRED IN THE PAST OR DURING COMPLAINT CALLS THAT MIGHT TRIGGER THE REASON COMPLAINT. UNIT PASSED THE SELF TEST, DISPLACEMENT ACCURACY TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST AND OCCLUSION TEST. UNIT ALSO PASSED THE SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT TEST. DURING DOWNLOAD HISTORY REVIEW NO RELEVANT ALARMS CONFIRM IN DOWNLOAD HISTORY FILES TO CONFIRM REASON CODE. THE BAAT TOOL WAS UTILIZED TO SEARCH FOR BATTERY RELATED ALARMS THAT MAY HAVE OCCURRED IN THE PAST OR AROUND THE COMPLAINT DATE THAT MIGHT OF TRIGGER THE REASON FOR COMPLAINT. THE BAAT TOOL RECORDED THE FOLLOWING: BATTERY CYCLE 3.0 RECEIVED THE LOWBATTERYALERT (104) ON 01/15/2027 00:37:00 AFTER MORE THAN 7 DAYS AT 22.97 DAYS. BATTERY CYCLE 2.0 RECEIVED THE LOWBATTERYALERT (104) ON 12/23/2026 01:14:00 AFTER MORE THAN 7 DAYS AT 25.64 DAYS. WITH REFERENCE TO THE BATTERY DURATION FAILURE ANALYSIS INSTRUCTIONS, THE CUSTOMER DID NOT EXPERIENCE AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS. THE POWER MANAGEMENT PARAMETERS GRAPH CONFIRMED THE UNLOADED VOLTAGE (UNLOADED VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. THE PUMP RECEIVED WITH NORMAL OPERATING CURRENTS. PROCEEDED BY CUTTING UNIT OPEN AND PERFORMING A VISUAL INSPECTION OF CONNECTORS AND ELECTRONIC ASSEMBLIES. PER VISUAL INSPECTION NO MOISTURE DAMAGE OR ANOMALIES NOTED DURING VISUAL INSPECTION AND ALL CONNECTORS WERE PLUGGED IN PROPERLY. THE FOLLOWING COSMETIC DAMAGES WERE NOTED: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED CASE, BATTERY TUBE THREADS - CRACKED AND CRACKED CASE (BATTERY TUBE). IN CONCLUSION, CUSTOMER CONCERNS ARE NOT CONFIRMED. UNABLE TO CONFIRM CUSTOMER ALLEGED CONCERN OF HIGH BGS. NO RELEVANT ALARMS NOTED IN DOWNLOAD HISTORY REVIEW AND TESTING OF THE UNIT WAS SUCCESSFUL. CUSTOMERS ALLEGED OF LOW BATTERY ALARM OR SHORT BATTERY LIFE WERE NOT CONFIRMED BASED ON BATTERY DURATION FAILURE ANALYSIS INSTRUCTION, THE CUSTOMER DID NOT EXPERIENCE AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS. NO UNEXPECTED ALARMS WERE NOTED AND SELF TEST PASSED SUCCESSFULLY. 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

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA WITH BLOOD GLUCOSE VALUE OF 550 MG/DL. THE CUSTOMER REPORTED HYPERGLYCEMIA WAS TREATED WITH LANTIS PEN SHORT AND FAST ACTING INSULIN. THE EVENT INVOLVED PRODUCT(S) MMT-332A, MMT-1884, MMT-396A. THE CUSTOMER REPORTED THE PUMP LOST POWER WITH NO ALARMS OR ERROR MESSAGES. IT WAS UNKNOWN WHETHER THE CUSTOMER WAS USING THE INSULIN PUMP WITHIN 48 HOURS OF THE REPORTED EVENT. THERE IS NO MENTION OF THE AUTO MODE FEATURE AT THE TIME OF THE EVENT. TROUBLESHOOTING WAS NOT PERFORMED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A, MMT-1884, MMT-396A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12898 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 NG3785220H

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other FRN-MMT-332A-RSVR, UNOMED INF SET.