BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 24724717 · Received March 30, 2026

    Report

    Report Number
    2032227-2026-150631
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 5, 2026
    Report Date
    March 29, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    PMA / PMN Number
    P150001
    Removal / Correction Number
    2032227-07-23-2024-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SELF TEST, ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. ALL BUTTONS FUNCTIONING PROPERLY. NO UNEXPECTED BATTERY ALERTS NOTED. NO UNEXPECTED INSULIN FLOW BLOCKED ALARMS NOTED DURING TESTING. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. DURING DOWNLOAD HISTORY REVIEW, NORMAL LOW BATTERY ALERTS OCCURRED ON 02/23/2026 19:33:00, 01/28/2026 19:52:00 AND 01/02/2026 08:23:00. BATTERY CYCLE 17.0 RECEIVED THE LOWBATTERYALERT (104) ON 02/23/2026 19:33:00 AFTER MORE THAN 7 DAYS AT 25.98 DAYS. BATTERY CYCLE 16.0 RECEIVED THE LOWBATTERYALERT (104) ON 01/28/2026 19:52:00 AFTER MORE THAN 7 DAYS AT 26.33 DAYS. BATTERY CYCLE 15.0 RECEIVED THE LOWBATTERYALERT (104) ON 01/02/2026 08:23:00 AFTER MORE THAN 7 DAYS AT 26.06 DAYS. WITH REFERENCE TO THE BATTERY DURATION FAILURE ANALYSIS INSTRUCTIONS, THE CUSTOMER DID NOT EXPERIENCE AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS. NO UNEXPECTED REWIND ANOMALY OR NO DELIVERY/INSULIN FLOW BLOCKED FOUND IN THE HISTORY FILES ON THE WEEK OF THE EVENT DAY OF 05-MAR-2026. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON PCBA 1 AND MOTOR. THE P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: DAMAGED DISPLAY WINDOW COVER, CRACKED KEYPAD OVERLAY, CRACKED CASE, BATTERY TUBE THREADS - CRACKED AND CRACKED CASE (BATTERY TUBE). CUSTOMER DID NOT EXPERIENCE AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY. CHARGE/BATTERY LASTS LESS THAN EXPECTED, FAILED BATTERY TEST, UNEXPECTED INSULIN FLOW BLOCKED ALARM, UNRESPONSIVE KEYPAD AND REWIND ANOMALY WERE NOT CONFIRMED. COSMETIC DAMAGE CONFIRMED AT THE BATTERY TUBE SIDE. EXPOSED TO MOISTURE DAMAGE ON PCBA 1 AND MOTOR. 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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 CRACKS IN THE CASING OF THE PUMP, HAD TO CHANGE OUT BATTERIES MORE OFTEN, THE PUMP HAS REJECTED NEW BATTERIES, THE BUTTONS ARE LESS RESPONSIVE, RECEIVED UNEXPLAINED NO DELIVERY ALERTS, AND THE PUMP IS LOUDER DURING REWIND. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) UNK_RESERVOIR, UNOMEDICAL, MMT-1880. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR UNK_RESERVOIR. NO PRODUCT RETURN IS REQUIRED FOR UNOMEDICAL. 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
    785684 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 HG5Q4R8ZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female