BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSMITTER MMT-7841ZN GST5G US

    MDR report key: 23995579 · Received January 7, 2026

    Report

    Report Number
    2032227-2026-103132
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    November 20, 2025
    Report Date
    January 7, 2026
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PQF
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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) 2025 16:59:10 DOP114-980DOC_VER_BB: TRANSMITTER DOES NOT BLINK WHEN CONNECTED TO SENSOR OR SENSOR WARM UP NOT STARTED CUSTOMER REPORTS THE TRANSMITTER DID NOT BLINK WHEN CONNECTED TO THE SENSOR OR SENSOR WARM UP NOT STARTED. TRANSMITTER WAS FULLY CHARGED PRIOR. LED LIGHT BLINKED WHEN TRANSMITTER WAS DISCONNECTED FROM THE CHARGER AND/OR CONNECTED TO TESTER BUT LED LIGHT WOULD NOT BLINK WHEN CONNECTED TO THE SENSOR. IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED THE LOSS OF COMMUNICATION BETWEEN INSULIN PUMP AND TRANSMITTER, THE TRANSMITTER DID NOT BLINK WHEN CONNECTED TO THE SENSOR. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-7040MA, MMT-1884, MMT-7841ZN. TROUBLESHOOTING WAS PERFORMED. TRANSMITTER WAS FULLY CHARGED PRIOR. LED LIGHT BLINKED WHEN TRANSMITTER WAS DISCONNECTED FROM THE CHARGER AND/OR CONNECTED TO TESTER BUT LED LIGHT WOULD NOT BLINK WHEN CONNECTED TO THE SENSOR. TROUBLESHOOTING WAS NOT PERFORMED FOR LOSS OF COMMUNICATION ISSUE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-7040MA. NO PRODUCT RETURN IS REQUIRED FOR MMT-1884. NO PRODUCT RETURN IS REQUIRED FOR MMT-7841ZN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55490 TRANSMITTER MMT-7841ZN GST5G US SENSOR, GLUCOSE, INVASIVE , NON-ADJUNCTIVE PQF MEDTRONIC MINIMED MMT-7841ZN 1170310

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male