BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 23970910 · Received January 5, 2026

    Report

    Report Number
    2032227-2026-101433
    Event Type
    Injury
    Date Received
    January 5, 2026
    Date of Event
    December 12, 2025
    Report Date
    January 5, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH WAS NOT INCLUDED IN THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN SECTION B5 (UPDATED SUMMARY) WITH THIS REPORT. 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

    UPDATED SUMMARY: AS PER ADDITIONAL INFORMATION RECEIVED, THE CUSTOMER REPORTED UNKNOWN BLOOD GLUCOSE VALUE. AND THE REPORTED SENSOR GLUCOSE VALUE WAS 52 MG/DL AND 68 MG/DL. HENCE, THE EVENT SUBMITTED UNDER REPORT NUMBER "2032227-2026-101433" IS NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED HYPOGLYCEMIA. THE BLOOD GLUCOSE VALUE AT THE TIME OF THE EVENT WAS 52 MG/DL. THE CUSTOMER WAS TREATED WITH GLUCOSE. THE EVENT INVOLVED PRODUCT(S) MMT-342 , ACC-1529, MMT-442AG, MMT-1884. TROUBLESHOOTING WAS NOT PERFORMED. IT WAS UNKNOWN WHETHER THE CUSTOMER WAS USING THE AUTO MODE/SMART GUARD FEATURE AT THE TIME OF THE EVENT. IT WAS UNKNOWN WHETHER THE CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-342. NO PRODUCT RETURN IS REQUIRED FOR ACC-1529. NO PRODUCT RETURN IS REQUIRED FOR MMT-442AG. NO PRODUCT RETURN IS REQUIRED FOR MMT-1884.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31770 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 NG3945403H

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other FRN-MMT-342-RSVR, UNOMED INF SET.