BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 23626780 · Received November 22, 2025

    Report

    Report Number
    2032227-2025-305099
    Event Type
    Malfunction
    Date Received
    November 22, 2025
    Date of Event
    October 30, 2025
    Report Date
    January 22, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000640095
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP PASSED THE DISPLACEMENT TEST, SELF-TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED PUMP ERROR 60 NOTED DURING TESTING. THE TEST SENSOR SIMULATOR, MOBILE DEVICE COMMUNICATES PROPERLY TO THE PUMP. NO DEVICE NOT FOUND, LOST SENSOR ALARM DURING TESTING. THUS AND SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. PUMP ERROR 60 SHOW IN THE TRACE/HISTORY FILES ON 10/30/2025 10:14:17.000, 10/30/2025 10:14:29.000. FILE NUMBER: 2002 32149 31 32149 31 32149 51 32149 51 2017 32149, LINE NUMBER: 1541 202 1747 202 1747 202 1451 202 1451 147 202, ESF# : (B)(4). POSSIBLE HARDWARE ERROR. NO MOISTURE DAMAGE ON THE ELECTRONICS, BATTERY CONNECTOR, BATTERY TUBE, MOTOR, VIBRATOR DURING VISUAL INSPECTION. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: UNIT HAD SCRATCHED CASE, STAINED KEYPAD OVERLAY, CRACKED BATTERY TUBE THREADS, CRACKED CASE (BATTERY TUBE). PUMP PASSED ALL TESTING REQUIRED. NO UNEXPECTED PUMP ERROR 60 DURING TESTING. HOWEVER, PUMP ERROR 60 SHOWS IN THE TRACE/HISTORY, PROBLEM ISOLATED TO HARDWARE ERROR ELECTRONIC DEFECTIVE. THE CUSTOMER ALLEGED THE PUMP HAVING TROUBLE COMMUNICATION SENSOR SIMULATOR AND MOBILE DEVICE NOT CONFIRMED. CRACKED CASE (BATTERY TUBE) 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. 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 PUMP ERROR 60 (TONE, VIBRATOR OR MOTOR DID NOT HAVE POWER AVAILABLE WHEN NEEDED), ISSUES WITH THE SCREEN, NO DATA RECEIVED FROM THE MOBILE APPLICATION AND TRANSMITTER. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1880. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ABLE TO CLEAR THE ALARM. CUSTOMER WAS UNABLE TO REWIND THE PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1880 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. THE CUSTOMER WILL DISCONTINUE USING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627979 MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880 NG3433538H 000000763000640095

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female