BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-7040MA GS3 5PK US

    MDR report key: 24644268 · Received March 19, 2026

    Report

    Report Number
    2032227-2026-146440
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    March 13, 2026
    Report Date
    March 19, 2026
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    (B)(6) 2026 07:01:37 DOP114-980DOC_VER_BC: AUTO MODE/SMARTGUARD - UNABLE TO ENTER AUTO BASAL CUST IS REQUESTING ASSISTANCE WITH ENTERING AUTO BASAL. REVIEWED AUTO MODE READINESS/SMARTGUARD CHECKLIST SCREEN. EXPLAINED WHAT WAS MISSING TO ENTER INTO AUTO MODE/SMARTGUARD AND HOW TO RESOLVE. (B)(6) 2026 07:01:37 DOP114-980DOC_VER_BC: HIGH BGS/UNDER DELIVERY CUSTOMER REPORTED HIGH BGS. (B)(6) 2026 07:01:37 DOP114-980DOC_VER_BC: SG VS. BG GUARDIAN SENSOR 3/GUARDIAN 4 SENSOR CUSTOMER IS REPORTING A DISCREPANCY BETWEEN SG AND BG WHICH IS NOT WITHIN RANGE AFTER FEWER THAN 4 DAYS OF WEAR. ADVISED TO WAIT AT LEAST AN HOUR AND IF BG IS STABLE TO CALIBRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696957 SENSOR MMT-7040MA GS3 5PK US AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7040MA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male