BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 23177864 · Received September 30, 2025

    Report

    Report Number
    2032227-2025-272344
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    September 9, 2025
    Report Date
    December 10, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. IN FURTHER CHECKING OF THE PUMP HISTORY RECORDS: BATTERY CYCLE 54.0 RECEIVED THE LOWBATTERYALERT (104) ON 08/24/2025 04:56:00 AFTER MORE THAN 7 DAYS AT 19.68 DAYS. BATTERY CYCLE 53.0 RECEIVED THE LOWBATTERYALERT (104) ON 08/03/2025 12:39:01 AFTER MORE THAN 7 DAYS AT 24.11 DAYS. BATTERY CYCLE 51.0 RECEIVED THE LOWBATTERYALERT (104) ON 07/09/2025 23:50:00 AFTER MORE THAN 7 DAYS AT 20.12 DAYS. CUSTOMER DID NOT EXPERIENCE AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS. POWER PROBLEM-BATTERY LOSS NOT CONFIRMED. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP. THE PUMP WAS RECEIVED WITH CRACKED BATTERY TUBE THREADS AND CRACKED CASE AT THE BATTERY TUBE SIDE. THE P-CAP LOCKS PROPERLY INTO THE RESERVOIR COMPARTMENT. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, STAINED SERIAL NUMBER LABEL, CRACKED CASE AT THE CORNER OF THE BELT CLIP RAIL, PILLOWING KEYPAD OVERLAY AND STAINED KEYPAD OVERLAY. THE PUMP WAS RECEIVED WITHOUT A BATTERY. THE PUMP WAS RECEIVED WITHOUT THE BATTERY CAP. PERFORM THE HISTORY REVIEW 1 WEEK PRIOR TO THE EVENT DATE 09-SEP-2025 IN THE PUMP HISTORY FILE AND FOUND 2 FAILEDBATTTEST (58) ON 09/04/2025, 1 PUMP ERROR 68 ON 09/04/2025, 2 PUMP ERROR 49 ON 09/04/2025, 3 PUMP ERROR 23 ON 09/04/2025, 2 BATTOUTLIMIT (6) ON 09/04/2025, 9 FAILEDBATTTEST (58) ON 09/09/2025, 1 PUMP ERROR 68 ON 09/09/2025, 2 PUMP ERROR 49 ON 09/09/2025, 1 PUMP ERROR 23 ON 09/09/2025, AND 2 BATTOUTLIMIT (6) ON 09/09/2025, THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. PUMP ERROR 23, PUMP ERROR 49, PUMP ERROR 68 AND BATTERY OUT LIMIT ALARM WERE EXPECTED DUE TO THE BATTERY REMOVED FOR MORE THAN 10 MINUTES AND THE PUMP RESET. FAILED BATTERY TEST ALARM WAS EXPECTED DUE TO THE CUSTOMER'S BATTERY INSERTED ON A BATTERY CHANGE DOES NOT HAVE SUFFICIENT VOLTAGE. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (22.3 MV). CUSTOMER DID NOT EXPERIENCE AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS. POWER PROBLEM-BATTERY LOSS NOT CONFIRMED. DAMAGE- CRACKED CASE BATTERY TUBE CONFIRMED AT THE BACK OF THE PUMP. 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 A FAILED BATTERY TEST; THE BATTERY COMPARTMENT OF THE INSULIN PUMP WAS DAMAGED. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1880. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE INSULIN PUMP. MMT-1880 WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THAT THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218706 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 NG3334849H

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female