MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL
Report
- Report Number
- 2032227-2026-135904
- Event Type
- Malfunction
- Date Received
- February 27, 2026
- Date of Event
- February 9, 2026
- Report Date
- May 4, 2026
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- PMA / PMN Number
- P160017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- 003
Narratives
PUMP ALARMED CRITICAL PUMP ERROR AFTER BATTERY INSTALLATION. UNIT SUCCESSFULLY DOWNLOADED TO THUMP. THE PUMP HISTORY DOWNLOAD CONFIRMED THE PUMP ALARMED 3 CONSECUTIVE PUMP ERROR 53 ALARMS (LINE NUMBER 334 FILE NUMBER 174) ON 02/09/2026 23:25:23, DUE TO SW ISSUE AS PER GLOBAL LOGIC ANALYSIS (B)(4). UNABLE TO PERFORM SELF-TEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST, ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT TEST DUE TO CRITICAL PUMP ERROR. NO MOISTURE DAMAGE NOTED TO THE MOTOR ASSEMBLY, PCB1 BOARD OR PCB2 BOARD DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED CASE BATTERY TUBE, STAINED KEYPAD OVERLAY AND CRACKED BATTERY TUBE THREADS. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DURING ANALYSIS AND TRIGGERED BY 3 CONSECUTIVE PUMP ERROR 53 ALARMS DUE TO SW ISSUE. 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.
PUMP ALARMED CRITICAL PUMP ERROR AFTER BATTERY INSTALLATION. UNIT SUCCESSFULLY DOWNLOADED TO THUMP. THE PUMP HISTORY DOWNLOAD CONFIRMED THE PUMP ALARMED 3 CONSECUTIVE PUMP ERROR 53 ALARMS (LINE NUMBER 334 FILE NUMBER 174) ON 02/09/2026 23:25:23, DUE TO SW ISSUE AS PER GLOBAL LOGIC ANALYSIS (B)(4). UNABLE TO PERFORM SELF-TEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST, ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT TEST DUE TO CRITICAL PUMP ERROR. NO MOISTURE DAMAGE NOTED TO THE MOTOR ASSEMBLY, PCB1 BOARD OR PCB2 BOARD DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED CASE BATTERY TUBE, STAINED KEYPAD OVERLAY AND CRACKED BATTERY TUBE THREADS. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DURING ANALYSIS AND TRIGGERED BY 3 CONSECUTIVE PUMP ERROR 53 ALARMS DUE TO SW ISSUE. 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.
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.
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED CRITICAL PUMP ERROR. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-6101, MMT-1884. TROUBLESHOOTING WAS PERFORMED. INSTRUCTED CUSTOMER THAT PUMP WILL BE REPLACED AND INSTRUCTED CUSTOMER TO REVERT TO BACKUP PLAN PER HEALTHCARE PROFESSIONAL INSTRUCTIONS AND PLACE PUMP IN STORAGE MODE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1884 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. THE CUSTOMER WILL DISCONTINUE USING THE DEVICE. PRODUCT RETURN IS NOT APPLICABLE FOR NON PHYSICAL DEVICES MMT-6101.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 571485 | 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 | NG3851889H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Male |