BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-5120D1 INSTINCT 780 1PK OUS 1

    MDR report key: 24941161 · Received April 21, 2026

    Report

    Report Number
    2032227-2026-163762
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    April 12, 2026
    Report Date
    April 21, 2026
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    SFI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 WAS UNABLE TO FIND SENSOR SIGNAL AND EXPERIENCED A LOSS OF COMMUNICATION BETWEEN THE INSULIN PUMP AND THE TRANSMITTER. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-5120D1. TROUBLESHOOTING WAS PERFORMED. PUMP AND SENSOR WOULD NOT PAIR AFTER TROUBLESHOOTING. CUSTOMER REPORTS PUMP IS ABLE TO PAIR WITH OTHER DEVICES, E.G. METER, MOBILE DEVICE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. PRODUCT RETURN FOR MMT-5120D1 IS NOT EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328598 SENSOR MMT-5120D1 INSTINCT 780 1PK OUS 1 SENSOR, GLUCOSE, INVASIVE, COMPONENT OF AUTOMATED INSULIN DELIVERY SYSTEM SFI MEDTRONIC MINIMED MMT-5120D1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown