BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 24187598 · Received January 27, 2026

    Report

    Report Number
    2032227-2026-114416
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    January 4, 2026
    Report Date
    April 8, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000545604
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    P-CAP LOCKED IN PLACE PROPERLY DURING TESTING. PROCEED BY USING ORIGINAL BATTERY CAP AND A NEW BATTERY. UNIT POWER UP PROPERLY AFTER BATTERY INSTALLATION. UNIT WAS DOWNLOADED SUCCESSFULLY USING (THUS SOFTWARE) FOR REFERENCE. THE ADAPT TOOL WAS UTILIZED TO SEARCH FOR ANY ALARMS THAT MAY HAVE OCCURRED IN THE PAST OR AROUND THE COMPLAINT DATE THAT MIGHT TRIGGER THE REASON COMPLAINT. THE ADAPT TOOL REVEALS FAILED BATT TEST ALARMS ON 01/04/2026 12:43:28.000 AND ON 01/04/2026 12:44:16.000. IN ADDITION, PUMP ERROR 43 AND 41 WERE ALSO RECORDED ON 01/04/2026 12:30:00.000 AND ON 01/04/2026 12:30:00.000 HOUR. PROCEEDED WITH THE FOLLOWING TESTING TO ASSURE PROPER FUNCTIONALITY OF THE UNIT. UNIT PASSED THE SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT. NO FAILED BATTERY ALARMS NOTED DURING TESTING. UNIT ALSO PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST AND SELF TEST. NO PUMP ERROR 43 OR 41 ALARM NOTED DURING REWIND OR DURING TESTING. UNIT FUNCTIONING PROPERLY. THE PUMP RECEIVED WITH NORMAL OPERATING CURRENTS. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. UNIT WAS CUT OPEN AND PERFORMED A VISUAL INSPECTION OF CONNECTORS AND ELECTRONIC ASSEMBLIES. PER VISUAL INSPECTION ALL CONNECTORS INCLUDING BATTERY FLEX CONNECTOR AND MOTOR FLEX CONNECTOR WERE PLUGGED IN PROPERLY. NO MOISTURE DAMAGE NOTED DURING VISUAL INSPECTION. ISOLATE TO MOTOR ASSEMBLY. UNIT WAS ALSO RECEIVED WITH THE FOLLOWING COSMETIC DAMAGES: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED CASE AND CRACKED CASE (BATTERY TUBE). IN CONCLUSION NO UNEXPECTED FAILED BATT TEST ALARMS NOTED DURING TESTING. UNIT FUNCTIONING PROPERLY AFTER BATTERY INSTALLATION. NO PUMP ERROR 41 OR 43 ALARMS NOTED DURING TESTING HOWEVER, THEY WERE RECORDED IN DOWNLOAD HISTORY FILES. ISOLATE TO MOTOR ASSEMBLY. 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. 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 PUMP ERROR 41 (MOTOR POWER SUPPLY VOLTAGE ERROR DETECTED. THIS IS MEASURED BEFORE EACH SINGLE PUMP STROKE, AND THEN CONTINUALLY MEASURED PERIODICALLY DURING THE ENTIRE MOTOR DRIVING PERIOD). THE CUSTOMER RECEIVED PUMP ERROR 43 (AN ERROR IN THE MOTOR WAS DETECTED BY READING AN UNEXPECTED VALUE FROM THE HALL SENSOR). THE CUSTOMER REPORTED RECEIVING A BATTERY FAILED ALARM. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1880. TROUBLESHOOTING WAS PERFORMED FOR THE PUMP ERROR. THE CUSTOMER WAS ABLE TO CLEAR THE ERROR AND WAS ABLE TO COMPLETE REWIND. TROUBLESHOOTING WAS PERFORMED FOR THE BATTERY FAILED ALARM, AND THE CUSTOMER REPORTED THAT BATTERY CAP CONTACTS AND BATTERY COMPARTMENT ARE NOT DAMAGED OR CORRODED. CUSTOMER RECEIVED ANOTHER BATTERY FAILED ALARM AFTER INSERTING A NEW BATTERY. THE CUSTOMER COMPLETED A PUMP RESTART AND INSERTED ANOTHER BATTERY. BATTERY FAILED ALARM DID NOT RECUR. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS INSTRUCTED TO DISCONTINUE DEVICE USE. MMT-1880 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
    253430 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 NG3387168H 000000763000545604

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female