BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 23023619 · Received September 11, 2025

    Report

    Report Number
    2032227-2025-256452
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    August 14, 2025
    Report Date
    November 14, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000734435
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP PASSED THE ACTIVE CURRENT TEST, SLEEP CURRENT TEST, DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST AND SELF TEST. NO UNEXPECTED ALARMS OR ALERTS NOTED DURING TESTING. NO PUMP ERROR 82 ALARM NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. FAILED BATTERY TEST ALERTS ON 08/14/2025 19:45:54, 08/14/2025 19:46:10 AND 08/14/2025 19:46:26, PUMP ERROR 4 ALARMED ON 08/14/2025 19:45:51.000, PUMP ERROR 60 ALARMED ON 8/14/2025 19:45:51.000 AND PUMP ERROR 82 WAS ALARMED ON 08/14/2025 19:45:43.000 WERE FOUND IN THE HISTORY FILE/LONG TRACE FILE. DURING SELF TEST, THE RED LED INDICATOR TURNED ON AND THE VIBRATOR MOTOR VIBRATED WITH BOTH FUNCTIONING PROPERLY WHICH INDICATES THE HARDWARE WORKED AS EXPECTED. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO PHYSICAL OR MOISTURE DAMAGE TO THE KEYPAD ASSEMBLY, ELECTRONIC ASSEMBLY, OR MOTOR ASSEMBLY. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED KEYPAD OVERLAY AND SCRATCHED CASE. FAILED BATTERY TEST, PUMP ERROR 4 AND PUMP ERROR 60 WERE NOT CONFIRMED DURING TESTING. PUMP ERROR 82 WAS CONFIRMED, HOWEVER UNABLE TO CONFIRM FOR SOFTWARE ANOMALY DUE TO INSUFFICIENT DATA IN THE DETAIL TRACE FILE, 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 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 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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED INSIDE THE UNITED STATES. 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 THE CUSTOMER RECEIVED PUMP ERROR 4 (THE MOTOR ARM CANNOT COMMUNICATE WITH THE MAIN ARM.), THE CUSTOMER RECEIVED PUMP ERROR 60 (TONE, VIBRATOR OR MOTOR DID NOT HAVE POWER AVAILABLE WHEN NEEDED.),THE CUSTOMER RECEIVED PUMP ERROR 82 (THE HRM TASK DID NOT GRANT MOTOR POWER IN REASONABLE TIME.) AND BATTERY FAILED ALARM. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1885. TROUBLESHOOTING WAS PERFORMED FOR PUMP ERROR ALARM. CUSTOMER WAS ABLE TO CLEAR THE ALARM BUT WAS ABLE TO COMPLETE THE REWIND PROCESS AND SELF TEST PASSED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL STOP USING THE DEVICE AND WAS TOLD TO REVERT TO THE BACKUP PLAN ACCORDING TO HEALTHCARE PROFESSIONAL INSTRUCTIONS. PRODUCT RETURN IS REQUIRED FOR MMT-1885.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2676635 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885 NG3687068H 000000763000734435

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown