BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 24761293 · Received April 1, 2026

    Report

    Report Number
    2032227-2026-152976
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    February 28, 2026
    Report Date
    April 1, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    ON (B)(6) 2026 10:57:21 (B)(4) _VER_BC: "UNEXPECTED RE-INITIALIZATION (UNEXPECTED "SENSOR CONNECTED" ALERT)" "CUSTOMER REPORTS AN UNEXPECTED RE-INITIALIZATION OR AN UNEXPECTED "SENSOR CONNECTED" ALERT. CUSTOMER CONTINUED USING SENSOR." ON (B)(6) 2026 10:57:21 (B)(4) _VER_BC: CHANGE SENSOR/SENSOR UPDATING/SG VALUE NOT AVAILABLE/CALIBRATION NOT ACCEPTED CUSTOMER REPORTS RECEIVING A SENSOR UPDATING /SG VALUE NOT AVAILABLE ALERT. ADVISED TO REPLACE SENSOR AS BEHAVIOR HAS BEEN OCCURRING LONGER THAN 3 HOURS. ON (B)(6) 2026 10:57:21 (B)(4) _VER_BC: LOW BGS/OVER DELIVERY CUSTOMER REPORTED LOW BGS. CUSTOMER HAS BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48HRS OF REPORTED LOW BG EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811765 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 NG3461001H

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Other RESERVOIR (FRN) / INFUSION SET (FPA).