BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 22648495 · Received July 29, 2025

    Report

    Report Number
    2032227-2025-219604
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    June 28, 2025
    Report Date
    September 16, 2025
    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
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING POWER UP, THE UNIT RECEIVED PUMP ERROR 43 DURING REWIND. UNABLE TO PERFORM THE DISPLACEMENT, REWIND, PRIME/SEATING, BASIC OCCLUSION, FORCE SENSOR, OCCLUSION TESTS OR VERIFY KEYPAD BUTTON ANOMALY DUE TO THE PUMP ERROR 43. THUS SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. IN FURTHER FULL REVIEW IN THE PUMP HISTORY FOUND MULTIPLE MOTOR DRIVE ERROR (43) ON EVENT DATE 06/28/2025 19:07:00.000, 06/28/2025 19:19:36.000, 06/28/2025 19:53:48.000, 06/28/2025 19:58:14.000. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION FOUND MOISTURE DAMAGE ELECTRONIC ASSEMBLY AND CORRODED MOTOR HOME SWITCH DURING VISUAL INSPECTION. 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, BROKEN BELT CLIP RAIL, LABEL DAMAGE. IN CONCLUSION, UNABLE VERIFY KEYPAD BUTTONS ANOMALY DUE TO THE PUMP ERROR 43. PUMP ERROR 43 ALARMS DURING REWIND AND IN THE TRACE/HISTORY FILES DUE TO CORRODED MOTOR HOME SWITCH, MOISTURE DAMAGE ELECTRONIC AND CRACKED CASE CORNER OF BELT CLIP RAILS 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 A PUMP ERROR 43(AN ERROR IN THE MOTOR WAS DETECTED BY READING AN UNEXPECTED VALUE FROM THE HALL SENSOR). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1880. TROUBLESHOOTING WAS PERFORMED FOR THE PUMP ERROR, AND THE CUSTOMER WAS UNABLE TO CLEAR THE ALARM. TROUBLESHOOTING WAS PERFORMED FOR THE KEYPAD ANOMALY. THE CUSTOMER REPORTED THAT THE BUTTON JUST POPS BACK UP ALSO STATED THAT THE PUMP WAS EXPOSED TO MOISTURE. TROUBLESHOOTING WAS PERFORMED FOR DAMAGE. THE CUSTOMER REPORTED DAMAGE TO THE BACK OF THE PUMP, AND THE FUNCTIONALITY OF THE PUMP WAS AFFECTED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND ADVISED TO REVERT TO A BACKUP PLAN PER THE HEALTHCARE PROFESSIONAL'S INSTRUCTIONS AND PLACE THE PUMP IN STORAGE MODE. TROUBLESHOOTING WAS PERFORMED FOR THE FLUID IN THE PUMP, AND THE CUSTOMER STATED THAT THE FLUID WAS IN THE PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE INSULIN PUMP. 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
    1384186 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 NG3247335H 000000763000545604

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male