BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 24530190 · Received March 6, 2026

    Report

    Report Number
    2032227-2026-140196
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    February 18, 2026
    Report Date
    May 4, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Removal / Correction Number
    2032227-07-23-2024-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED ACTIVE CURRENT TEST, SLEEP CURRENT TEST, AND SELF-TEST. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. NO FAILED BATTERY TEST NOTED. NO REPLACE BATTERY NOW ALARM NOTED. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. VERIFIED PUMP ALARMED FAILED BATTERY TEST ON 02/18/2026 01:34:27 IN PUMP DOWNLOADED HISTORY. BATTERY CYCLE 29.0 RECEIVED THE LOWBATTERYALERT (104) ON 02/17/2026 18:26:00 FASTER THAN EXPECTED AT 0.0 DAYS. BATTERY CYCLE 28.0 RECEIVED THE LOWBATTERYALERT (104) ON 02/17/2026 18:23:00 FASTER THAN EXPECTED AT 0.0 DAYS. BATTERY CYCLE 2.0 RECEIVED THE LOWBATTERYALERT (104) ON 01/19/2026 17:49:00 AFTER MORE THAN 7 DAYS AT 10.37 DAYS. CUSTOMER EXPERIENCED AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS. FOUND MOISTURE DAMAGE TO MOTOR ASSEMBLY, PCB1 BOARD AND PCB2 BOARD DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CORRODED ELECTRONIC ASSEMBLIES, CORRODED MOTOR HOME SWITCH, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED CASE CORNER OF THE BELT CLIP RAILS NEAR THE BATTERY COMPARTMENT, CRACKED BATTERY TUBE THREADS, FADED SERIAL NUMBER LABEL, STAINED AND CRACKED KEYPAD OVERLAY. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. NO FAILED BATTERY TEST NOTED AND PASSED ALL REQUIRED TESTING. CUSTOMER EXPERIENCED AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS. CONFIRMED MOISTURE DAMAGE TO THE MOTOR ASSEMBLY, PCB1 BOARD AND PCB 2 BOARD. NO REPLACE BATTERY NOW ALARM 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 REPORTED SHORT BATTERY LIFE, RECEIVED REPLACE BATTERY NOW ALARM AND BATTERY FAILED ALARM. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884. TROUBLESHOOTING WAS PERFORMED FOR REPLACE BATTERY ALARM. CUSTOMER RECEIVE A LOW BATTERY ALERT PRIOR TO REPLACE BATTERY ALERT. THIS WAS THE SECOND OCCURRENCE OF RECEIVING ALARM IN LESS THAN 8 HOURS AFTER LOW BATTERY WARNING. NO DAMAGE WAS REPORTED ON BATTERY CAP CONTACTS OR BATTERY COMPARTMENT. ADVISED CUSTOMER THAT PUMP WILL BE REPLACED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1884 WAS REQUESTED, AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56538 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 NG3473414H

    Patients

    Seq Age Sex Outcome Treatment
    1