BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 23048591 · Received September 15, 2025

    Report

    Report Number
    2032227-2025-258997
    Event Type
    Injury
    Date Received
    September 15, 2025
    Date of Event
    August 14, 2025
    Report Date
    December 19, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT PASSED SELF-TEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DISPLACEMENT ACCURACY TEST. UNIT WAS SUCCESSFULLY DOWNLOADED USING THUMP. NO UNEXPECTED ALARMS/ALERT/ANOMALIES NOTED DURING TESTING. UNABLE TO VERIFY HIGH BG'S. CONFIRMED 1103000 (110.3 U) UNITS OF NORMAL BOLUS WAS DELIVERED ON AUG 14, 2025. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND¿EVIDENCE OF MOISTURE DAMAGE¿ON THE ELECTRONIC ASSEMBLY. P-CAP WAS ATTACHED AND LOCKED INTO PLACE PROPERLY. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: PILLOWING KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, SCRATCHED CASE, CRACKED CASE-CORNER OF BELT CLIP RAILS AND BATTERY TUBE THREADS - CRACKED. NO UNEXPECTED ALARMS/ALERT/ANOMALIES NOTED DURING TESTING, UNABLE TO VERIFY HIGH BG'S. NO DEVICE PROBLEM FOUND WAS CONFIRMED. COSMETIC DAMAGES WERE NOTED DURING VISUAL INSPECTION. EXPOSED TO MOISTURE 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 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 HYPERGLYCEMIA. THE CUSTOMER REPORTED INFUSION SET BENT. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 400 MG/DL. THE CUSTOMER REPORTED HYPERGLYCEMIA TREATED WITH INSULIN PUMP (SUBCUTANEOUS INSULIN INFUSION). THE EVENT INVOLVED PRODUCT(S) UNOMEDICAL, MMT-1884, MMT-332A. TROUBLESHOOTING WAS PERFORMED FOR INFUSION SET BENT. TROUBLESHOOTING WAS DECLINED FOR THE REPORTED HARM. IT WAS UNKNOWN THAT THE CUSTOMER WAS USING THE PUMP FOR 48 HOUR BEFORE THE REPORTED EVENT AND UNKNOWN THAT THE CUSTOMER WAS USING THE AUTO MODE/SMARTGUARD FEATURE AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR UNOMEDICAL, MMT-1884, MMT-332A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2499084 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 HG5EGH3ZZ

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Other FRN-MMT-332A-RSVR, UNOMED INF SET