BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 25120458 · Received May 8, 2026

    Report

    Report Number
    2032227-2026-171433
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    April 18, 2026
    Report Date
    May 7, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    QJS
    UDI-DI
    000076300096003201
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    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 RECEIVED A CHANGE SENSOR, AND SENSOR UPDATING ALERT. THE CUSTOMER REPORTED A BLOOD GLUCOSE VALUE OF 342 MG/DL. THE CUSTOMER EXPERIENCED HYPERGLYCEMIA AND WAS TREATED WITH AN IV INSULIN DRIP (INTRAVENOUS INSULIN INFUSION). THE EVENT INVOLVED PRODUCT(S) MMT-332A, MMT-213A, MMT-7040B, AND MMT-1884. TROUBLESHOOTING WAS PERFORMED FOR THE CHANGE SENSOR ALERT, AND THE CUSTOMER IS UNABLE TO RUN A TRANSMITTER TEST AND/OR TEST PASSED. TROUBLESHOOTING WAS PARTIALLY PERFORMED FOR THE HIGH BLOOD GLUCOSE. IT WAS UNKNOWN WHETHER THE CUSTOMER WAS USING THE PUMP WITHIN 48 HOURS BEFORE THE EVENT AND WHETHER THE AUTO MODE FEATURE WAS ACTIVE OR NOT AT THE TIME OF THE EVENT NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A, MMT-213A, MMT-7040B, AND MMT-1884.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280370 MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER, INSULIN SUSPEND QJS MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1884 NG4290445H 000076300096003201

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other FRN-MMT-332A-RSVR, UNOMED INF SET.| OZP-MMT-7040B-SNSR.