BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 22686942 · Received August 1, 2025

    Report

    Report Number
    2032227-2025-224148
    Event Type
    Malfunction
    Date Received
    August 1, 2025
    Date of Event
    July 3, 2025
    Report Date
    October 4, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT PASSED THE SELF-TEST, DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST AND OCCLUSION TEST. UNIT PASSED DAT AT 0.0874 INCHES. NO UNEXPECTED INSULIN FLOW BLOCKED ALARMS NOTED DURING TESTING, AND P-CAP LOCKS PROPERLY INTO THE RESERVOIR COMPARTMENT. UNIT SUCCESSFULLY DOWNLOADED TO THUMP. CONFIRMED PUMP ALARMED INSULIN FLOW BLOCKED ALARM ON 07/03/2025 07:29:35.000 DURING BOLUS, 07/03/2025 08:32:40.000 DURING BOLUS, 07/03/2025 08:34:30.000 DURING BOLUS, 07/03/2025 08:35:22.000 DURING BOLUS AND 07/03/2025 08:37:16.000 DURING BOLUS FOUND IN PUMP DOWNLOADED HISTORY. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON MOTOR. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED KEYPAD OVERLAY, KEYPAD OVERLAY TEXTURE DAMAGE, MISSING DISPLAY WINDOW/COVER, CRACKED CASE, BATTERY TUBE THREADS - CRACKED, SERIAL NUMBER LABEL MISSING AND CRACKED CASE-CORNER OF BELT CLIP RAILS NO DELIVERY/OCCLUSION ALARM, UNEXPECTED INSULIN FLOW BLOCKED ALARM WAS NOT CONFIRMED. UNABLE TO CONFIRM HIGH BGS. EXPOSED TO MOISTURE CONFIRMED DUE TO DRIED INSULIN ON MOTOR SLIDE. 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 EXPERIENCED HYPERGLYCEMIA WITH BLOOD GLUCOSE VALUE AT THE TIME OF EVENT WAS 287 MG/DL.. THE CUSTOMER ALSO REPORTED INSULIN FLOW BLOCK ALARM AND FAULTY EXTENDED INFUSION SET, TUBING GOT CRIMPED. THE CUSTOMER WAS TREATED WITH INSULIN PUMP, MANUAL INJECTION. THE EVENT INVOLVED PRODUCT(S) MMT-1884, MMT-342, MMT-442AG. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS USING THE AUTO MODE/SMART GUARD FEATURE AT THE TIME OF THE EVENT. THE CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED EVENT. THE CUSTOMER REPORTED RECURRING INSULIN FLOW BLOCKED ALARMS AFTER TROUBLESHOOTING. THE CUSTOMER HAD TRIED ALL REMEDIES OR DOES NOT WANT TO TROUBLESHOOT FOR RECURRING ALARMS. THE CUSTOMER REPORTED SLIGHT BEND/CURVE IN CANNULA, WHICH WAS NORMAL AS CANNULA DESIGNED TO BE FLEXIBLE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE INSULIN PUMP. MMT-1884 WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THAT THE DEVICE WILL BE RETURNED. NO PRODUCT RETURN IS REQUIRED FOR MMT-342 . THE CUSTOMER WILL DISCONTINUE USE OF THE INFUSION SET. MMT-442AG WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THAT THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2277744 MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1884 HG68THW

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male