BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR MMT-5120D1 INSTINCT 780 1PK OUS 1

    MDR report key: 24899832 · Received April 16, 2026

    Report

    Report Number
    2032227-2026-161598
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    April 7, 2026
    Report Date
    April 16, 2026
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    SFI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 A DIFFERENCE BETWEEN SENSOR GLUCOSE AND BLOOD GLUCOSE VALUES. THE CUSTOMER REPORTED HYPERGLYCEMIA WITH BG VALUE OF 400 MG/DL. THE EVENT INVOLVED PRODUCT(S) MMT-5120D1. TROUBLESHOOTING WAS PERFORMED AND THE BLOOD GLUCOSE VALUE WAS 400 MG/DL AND THE SENSOR GLUCOSE VALUE WAS 90 MG/DL. THE DIFFERENCE BETWEEN THE SENSOR GLUCOSE AND BLOOD GLUCOSE VALUES WAS NOT WITHIN THE RANGE. EXPLAINED SENSOR MAY HAVE NO LONGER BEEN RESPONDING TO GLUCOSE CHANGES AND EXPLAINED POSSIBLE CAUSES. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN WAS REQUIRED FOR MMT-5120D1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966223 SENSOR MMT-5120D1 INSTINCT 780 1PK OUS 1 SENSOR, GLUCOSE, INVASIVE, COMPONENT OF AUTOMATED INSULIN DELIVERY SYSTEM SFI MEDTRONIC MINIMED MMT-5120D1 HG92RG9

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown