BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 23299858 · Received October 15, 2025

    Report

    Report Number
    2032227-2025-284783
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 29, 2025
    Report Date
    April 6, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, AND OCCLUSION TEST. TEST P-CAP AND RESERVOIR LOCKS PROPERLY INTO THE RESERVOIR COMPARTMENT, HOWEVER A PARTIALLY BROKEN RETAINER RING AT THE KNIT LINE. NO DELIVERY ALARMS WERE NOT NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED PUMP HISTORY FILES AND TRACES USING THUMP SOFTWARE. PUMP ALARMED NO RELEVANT NO DELIVERY ALARMS ON THE EVENT DATE OF (B)(6) 2025 IN THE PUMP HISTORY FILES AND TRACES. FOUND NO RELEVANT FAILED BATTERY TEST ALARMS IN THE PUMP HISTORY FILES AND TRACES ON THE EVENT DATE OF (B)(6) 2025. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR, AND FORCE SENSOR. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: CRACKED CASE, SCRATCHED CASE, MISSING DISPLAY WINDOW/COVER, STAINED KEYPAD OVERLAY, CRACKED CASE (BATTERY TUBE), CRACKED CASE-CORNER OF BELT CLIP RAILS, PARTIALLY BROKEN RETAINER, PILLOWING KEYPAD OVERLAY, LABEL DAMAGE, AND RETAINER KNIT LINE DAMAGE. NO DELIVERY/OCCLUSION ALARM WAS NOT CONFIRMED DURING TESTING. FAILED BATTERY TEST WAS NOT CONFIRMED DURING TESTING. COSMETIC DAMAGE WAS CONFIRMED AT THE BATTERY COMPARTMENT AND PUMP CASE. BROKEN RETAINER RING WAS 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.

    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 A HAIRLINE FRACTURE ON THE BACK OF THE PUMP NEAR THE BOTTOM CORNER, THE PUMP WAS REJECTING THE NEW BATTERIES, AND RECEIVED RANDOM NO DELIVERY ALARMS. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884, UNOMEDICAL, UNK_RESERVOIR. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-1884. NO PRODUCT RETURN IS REQUIRED FOR UNOMEDICAL. NO PRODUCT RETURN IS REQUIRED FOR UNK_RESERVOIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019319 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 HG5GU5LZZ

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female