MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL
Report
- Report Number
- 2032227-2025-308887
- Event Type
- Malfunction
- Date Received
- December 1, 2025
- Date of Event
- November 3, 2025
- Report Date
- February 2, 2026
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000076300096003201
- PMA / PMN Number
- P160017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
UNIT PASSED THE DISPLACEMENT TEST AND SELF TEST. PUMP SUCCESSFULLY DOWNLOADED TRACES AND HISTORY FILES USING THUMP. NO UNEXPECTED PUMP ERROR 23 OR PUMP ERROR 15 ALARMS NOTED DURING TESTING, HOWEVER PUMP ERROR 15 (FILE NUMBER = 38; LINE NUMBER = 440) FOUND IN PUMP HISTORY/TRACE FILES ON 11/03/2025 AT 21:20:09.000. PUMP ERROR 23 CONFIRMED IN THE PUMP HISTORY/TRACE FILES ON 11/03/2025 AT 21:20:11.000. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR OR FORCE SENSOR. PUMP PROPERLY PAIRED GUARDIAN LINK [4] TRANSMITTER. NO COMMUNICATION ANOMALY NOTED. SC1-CAP LOCKS PROPERLY INTO PLACE. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY, AND STAINED KEYPAD OVERLAY. ALLEGED NO COMMUNICATION BETWEEN PUMP AND TRANSMITTER NOT CONFIRMED DURING TESTING. UNEXPECTED PUMP ERROR 23 ALARMS CONFIRMED IN THE PUMP HISTORY/TRACE FILES ON 11/03/2025 AT 21:20:11.000 AS A RESULT OF AN UNEXPECTED RESTART CAUSED BY PUMP ERROR 15 ALARM. PUMP ERROR 15 (FILE NUMBER = 38; LINE NUMBER = 440) ALARM CONFIRMED IN THE PUMP HISTORY/TRACE FILES ON 11/03/2025 AT 21:20:09.000 DUE TO SUSPECTED HARDWARE ERROR AS PER GLOBAL LOGIC ANALYSIS (ESF #3764385). PROBLEM ISOLATED TO THE ELECTRONIC ASSEMBLIES. 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 INFORMATION HAS BEEN RECEIVED REGARDING THE NEW SVN(MMT-7040A) ADDITION WHICH WAS NOT INCLUDED IN THE INITIAL REPORT. SO, THE ADDITIONAL INFORMATION WAS ADDED IN B5 SECTION WITH THIS REPORT. 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. 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.
UPDATED SUMMARY AS PER ADDITIONAL INFORMATION RECEIVED: THE EVENT INVOLVED PRODUCTS MMT-1884, MMT-7040A. THE PRODUCT MMT-1884 WAS REQUESTED, AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE AND REVERT TO THE BACKUP PLAN AS PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. NO PRODUCT RETURN WAS REQUIRED FOR MMT-7040A.
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED A LOSS OF COMMUNICATION BETWEEN PUMP AND TRANSMITTER AS PUMP LOST CONNECTION TO THE SENSOR. THE CUSTOMER ALSO RECEIVED PUMP ERROR 15 (THE CRITICAL BLOCK AND INVERSE CRITICAL BLOCK DID NOT ADD TO ZERO) AND PUMP ERROR 23 (POST-RESET RAM CRC ALARM). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER WAS ABLE TO CLEAR ERROR AND COMPLETE REWIND PROCESS. THE PUMP WAS NOT RECENTLY PLACED IN STORAGE MODE OR WITHOUT A BATTERY FOR GREATER THAN 8 HOURS. NO HARM REQUIRING MEDICAL INTERVENTIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE. THE PRODUCT MMT-1884 WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1842613 | 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 | NG4199851H | 000076300096003201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Female |