BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 21615166 · Received March 16, 2025

    Report

    Report Number
    2032227-2025-136450
    Event Type
    Malfunction
    Date Received
    March 16, 2025
    Date of Event
    June 25, 2024
    Report Date
    May 23, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000439859
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED ACTIVE CURRENT TEST, SLEEP CURRENT TEST AND SELF-TEST. 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. NO ALARMS OR ALERTS NOTED DURING TESTING. WITH REFERENCE TO THE BATTERY DURATION FAILURE ANALYSIS INSTRUCTIONS, THE CUSTOMER EXPERIENCED AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR AND MOTOR HOME SWITCH. P-CAP LOCKS PROPERLY INTO THE RESERVOIR COMPARTMENT. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: PILLOWING KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY, SCRATCHED CASE, CRACKED CASE, CRACKED CASE-CORNER OF BELT CLIP RAILS, BATTERY TUBE THREADS - CRACKED AND LABEL DAMAGE (STAINED AND FADED). UNEXPECTED BATTERY POWER LOSS WAS CONFIRMED, ISOLATED TO ELECTRONIC STACK. CHARGE/BATTERY LASTS LESS THAN EXPECTED WAS CONFIRMED, ISOLATED TO ELECTRONIC STACK. COSMETIC DAMAGES WERE NOTED DURING VISUAL INSPECTION. 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 LOW BATTERY LIFE IN THE PUMP. CUSTOMER REPORTED THAT NEEDS TO CHANGE THE BATTERY AFTER 18 HOURS. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1880. TROUBLESHOOTING WAS PERFORMED LOW BATTERY ALERT. CUSTOMER CONFIRMED RECEIVING REPLACE BATTERY ALERT/ REPLACE BATTERY NOW ALARM. THIS WAS THE SECOND OCCURRENCE OF RECEIVING ALARM IN LESS THAN 8 HOURS AFTER LOW BATTERY WARNING. TROUBLESHOOTING WAS PERFORMED FOR REPLACE BATTERY ALERT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE PUMP AND REVERT TO A BACKUP PLAN PER HEALTHCARE PROFESSIONAL INSTRUCTIONS. MMT-1880 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562028 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 HG4Z23JZZ 000000763000439859

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male