BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR MMT-5120C INSTINCT 780 5PK OUS 1

    MDR report key: 23858268 · Received December 19, 2025

    Report

    Report Number
    2032227-2025-325198
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    November 25, 2025
    Report Date
    December 19, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    SFI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED INSIDE THE UNITED STATES. 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 HYPOGLYCEMIA DUE TO DISCREPANCY IN BLOOD GLUCOSE AND SENSOR GLUCOSE. INSULIN DELIVERY WAS SUSPENDED DUE TO LOW SENSOR GLUCOSE AND CUSTOMER RECEIVED CHANGE SENSOR ALERT. THE EVENT INVOLVED PRODUCT(S) MMT-5120C1. TROUBLESHOOTING WAS PERFORMED AND BLOOD GLUCOSE WAS 49 MG/DL AND SENSOR GLUCOSE WAS 248 MG/DL AND THE DIFFERENCE BETWEEN BLOOD GLUCOSE AND SENSOR GLUCOSE WAS NOT WITHIN THE RANGE. TROUBLESHOOTING WAS NOT PERFORMED FOR HYPOGLYCEMIC EVENT. IT WAS UNKNOWN WHETHER THE CUSTOMER WAS USING THE INSULIN PUMP WITHIN 48 HOURS OF THE REPORTED EVENT. THERE IS NO MENTION OF THE AUTO MODE FEATURE AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. PRODUCT RETURN FOR MMT-5120C1 IS NOT EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2605790 SENSOR MMT-5120C INSTINCT 780 5PK OUS 1 SENSOR, GLUCOSE, INVASIVE, COMPONENT OF AUTOMATED INSULIN DELIVERY SYSTEM SFI MEDTRONIC MINIMED MMT-5120C1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other