BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-7040C2 GUARDIAN4 5PK OUS 2

    MDR report key: 22672116 · Received July 30, 2025

    Report

    Report Number
    2032227-2025-222218
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    November 10, 2023
    Report Date
    July 30, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW PER CAPA 686868. 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 THAT THE CUSTOMER EXPERIENCED SENSOR GLUCOSE VS. BLOOD GLUCOSE. BLOOD GLUCOSE VALUE WAS 11 MMOL/L WHILE SENSOR GLUCOSE VALUE WAS 3 MMOL/L. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-7040C2. THE SENSOR WAS WORN FOR UNKNOWN NUMBER OF DAYS. HAD 12 SENSORS WITH THESE ISSUES IN A PERIOD OF 2 MONTHS. USER WOULD GET SENSOR UPDATING AND THEN CHANGE SENSOR ALERT. CALIBRATION WOULD ALSO NOT BE ACCEPTED DUE TO SG V BG. USER WAS EXPLAINED ALERT MAY BE CAUSED BY POSSIBLE ISSUE WITH SENSOR, POSSIBLE CONNECTION ISSUE BETWEEN TRANSMITTER AND SENSOR, OR POTENTIAL SENSOR PULL OUT. NO PRODUCT RETURN IS EXPECTED FOR MMT-7040C2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445983 SENSOR MMT-7040C2 GUARDIAN4 5PK OUS 2 AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7040C2

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Unknown