BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 23071947 · Received September 17, 2025

    Report

    Report Number
    2032227-2025-261475
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    August 23, 2025
    Report Date
    November 6, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO FROZEN SCREEN DURING TESTING. PUMP WAS RECEIVED WITH ERROR 3 ALARM DURING REWIND. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, AND SELF TEST DUE TO PUMP ERROR 3 ALARM. SUCCESSFULLY UTILIZED CREST AND THUS TO DOWNLOAD HISTORY FILES, TRACES. FOUND IN THE PUMP HISTORY MULTIPLE PUMP ERROR 3 ALARMS ON 08/23/2025 16:46:34.000, 08/23/2025 17:17:12.000, 08/23/2025 12:18:16.000, 08/23/2025 12:20:40. PUMP ERROR 43 ON 08/23/2025 14:52:55.000, 08/23/2025 14:54:05.000, 08/23/2025 14:35:47.000, 08/23/2025 15:51:23.000 AND PUMP ERROR 130 ON 08/23/2025 14:35:50.000, 08/23/2025 14:42:33.000, 08/23/2025 14:44:30.000, 08/23/2025 17:17:06. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON ELECTRONIC ASSEMBLY, MOTOR, AND FORCE SENSOR. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, CRACKED KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, CRACKED BATTERY TUBE THREADS, CRACKED CASE CORNER OF BELT CLIP RAILS. FROZEN SCREEN NOT IS CONFIRMED. PUMP ERROR 3 ALARM DURING TESTING AND PUMP ERROR 3, 43, 130 ALARMS IN FILE HISTORY DUE TO MOISTURE DAMAGED ELECTRONIC ASSEMBLY 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 RECEIVED AN ALARM WAS GENERATED WHEN THE PUMP DETECTED MOVEMENT IN THE HALL SENSOR COUNTS THAT WAS UNEXPECTED SINCE THE PUMP DID NOT COMMAND MOTOR MOVEMENT (PUMP ERROR 130). THE CUSTOMER RECEIVED AN ERROR IN THE MOTOR THAT WAS DETECTED BY READING AN UNEXPECTED VALUE FROM THE HALL SENSOR (PUMP ERROR 43). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884. TROUBLESHOOTING WAS PERFORMED FOR THE PUMP ERROR., AND THE CUSTOMER WAS ABLE TO CLEAR THE ERROR BUT WAS UNABLE TO COMPLETE THE REWIND PROCESS. TROUBLESHOOTING WAS PERFORMED FOR THE FROZEN DISPLAY, AND THE CUSTOMER CALLED BACK AFTER INSTALLING A NEW BATTERY, MONITORING THE PUMP FOR 2 HOURS, AND THE FROZEN DISPLAY RECURRED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ADVISED TO REVERT TO THE BACKUP PLAN PER THE HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. MMT-1884 WAS REQUESTED, AND THE CUSTOMER'S RESPONSE WAS THAT THE DEVICE WOULD BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1732069 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 HG5XECLZZ

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female