BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-7040C1 GUARDIAN4 5PK OUS 1

    MDR report key: 23830833 · Received December 17, 2025

    Report

    Report Number
    2032227-2025-310305
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    September 25, 2023
    Report Date
    December 2, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW PER CAPA (B)(4). 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. FOLLOWING OUR RECEIPT OF THE THREE RETURNED USED SENSOR AND PERFORMED VISUAL INSPECTION TO ONE RANDOM SENSOR AND CHECKED FOR PHYSICAL DAMAGE AND NONE WAS FOUND (UNDER NAKED EYE). THEN PERFORMED CONTINUITY RESISTANCE TEST TO VERIFY (OPEN TRACE), ELECTRICAL INTERRUPTION IN THE SENSOR CIRCUIT AND SENSOR PASSED PER SPECIFICATION. PERFORMED BICARBONATE BUFFER TEST AND SENSOR PASSED PER SPECIFICATIONS WITH ACCURATE READINGS. SEE ATTACHED FILE FOR RESULTS. IN SUMMARY, SENSOR PASSED PER SPECIFICATIONS SUBMERGE SENSOR UNDER DIFFERENT LEVELS OF GLUCOSE AND SENSOR PASSED WITH ACCURATE READINGS. UNABLE TO CONFIRM CUSTOMER COMPLAINT OF SG V BG. 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 80 MG/DL WHILE SENSOR GLUCOSE VALUE WAS 160 MG/DL. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-7040C1. IT WAS EXPLAINED TO THE CUSTOMER THAT THE SENSOR MAY HAVE NO LONGER BEEN RESPONDING TO GLUCOSE CHANGES AND EXPLAINED POSSIBLE CAUSES. NO PRODUCT RETURN IS EXPECTED FOR MMT-7040C1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2248016 SENSOR MMT-7040C1 GUARDIAN4 5PK OUS 1 AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7040C1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown