BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 25305585 · Received May 27, 2026

    Report

    Report Number
    2032227-2026-179855
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    May 5, 2026
    Report Date
    May 24, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    QJS
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 ALLEGED DIFFERENCE BETWEEN SENSOR GLUCOSE AND BLOOD GLUCOSE VALUES, UNEXPECTED SUSPEND [LOW SG]. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884, 78893-01. TROUBLESHOOTING WAS PERFORMED. INSULIN DELIVERY WAS SUSPENDED. BLOOD GLUCOSE VALUE WAS 173 MG/DL AND SENSOR GLUCOSE VALUE WAS 106 MG/DL AT THE TIME OF EVENT. THE DIFFERENCE BETWEEN BLOOD GLUCOSE AND SENSOR GLUCOSE WAS WITHIN THE ACCEPTABLE RANGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-1884, 78893-01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426807 MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER, INSULIN SUSPEND QJS MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1884 NG4085626H

    Patients

    Seq Age Sex Outcome Treatment
    1