BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-7040A GUARDIAN4 5PK US

    MDR report key: 23351060 · Received October 21, 2025

    Report

    Report Number
    2032227-2025-287997
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    January 6, 2024
    Report Date
    October 21, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW PER CAPA 686868. 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 THAT THE CUSTOMER EXPERIENCED SENSOR GLUCOSE VS. BLOOD GLUCOSE. BLOOD GLUCOSE VALUE WAS 220 MG/DL WHILE SENSOR GLUCOSE VALUE WAS 40 MG/DL. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-7040A. THE SENSOR WAS WORN FOR 4 DAYS OR MORE. USER HAD BLOOD AT SITE INSERTION. USER ALSO GOT A SENSOR UPDATING AND CHANGE SENSOR ALERT ON 2 OTHER SENSORS, DID NOT STATE IF THESE HAD THE SG V BG DIFFERENCE. CUSTOMER WAS ADVISED SENSOR MAY NO LONGER BE RESPONDING TO GLUCOSE CHANGES, MOST LIKELY DUE TO A SENSOR NOT SITUATED PROPERLY IN THE ISF PREVENTING SENSOR FROM PROPERLY TRACKING CHANGES IN GLUCOSE AND MAY ALSO BE RELATED TO SITE LOCATION/ROTATION, INSERTION TECHNIQUE OR TAPE TYPE/TECHNIQUE. NO PRODUCT RETURN IS EXPECTED FOR MMT-7040A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1841509 SENSOR MMT-7040A GUARDIAN4 5PK US AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7040A

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Unknown