BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSMITTER MMT-7841ZW GST5G OUS

    MDR report key: 24285294 · Received February 6, 2026

    Report

    Report Number
    2032227-2026-122337
    Event Type
    Malfunction
    Date Received
    February 6, 2026
    Date of Event
    February 2, 2026
    Report Date
    March 11, 2026
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PQF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH WAS NOT INCLUDED IN THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN SECTION B5 WITH THIS REPORT. 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.

    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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    UPDATED SUMMARY : AS PER THE CASE UPDATE, IT WAS CONFIRMED CUSTOMER DID NOT ALLEGED LOSS OF COMMUNICATION AND ALSO TRANSMITTER IS OUT OF WARRANTY. HENCE, THE EVENT SUBMITTED UNDER REPORT NUMBER "2032227-2026-122337" IS NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE TRANSMITTER DID NOT BLINK WHEN CONNECTED TO SENSOR AND THERE WAS NO SIGNAL. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-7841ZW. TROUBLESHOOTING WAS PERFORMED AND TRANSMITTER DID NOT BLINK AS EXPECTED WHEN CONNECTED TO THE TESTER AND/OR REMOVED FROM THE CHARGER. TRANSMITTER LED LIGHT MAY NOT BE WORKING PROPERLY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-7841ZW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346473 TRANSMITTER MMT-7841ZW GST5G OUS SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE PQF MEDTRONIC MINIMED MMT-7841ZW 1125542

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown