BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-7040A GUARDIAN4 5PK US

    MDR report key: 24613151 · Received March 16, 2026

    Report

    Report Number
    2032227-2026-145022
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    March 10, 2026
    Report Date
    March 16, 2026
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 10:32:59 DOP114-980DOC_VER_BC: SG VS. BG GUARDIAN SENSOR 3/GUARDIAN 4 SENSOR CUSTOMER IS REPORTING A DISCREPANCY BETWEEN SG AND BG. (B)(6) 2026 10:32:59 DOP114-980DOC_VER_BC: INSULIN FLOW BLOCKED ALARM CUSTOMER REPORTED INSULIN FLOW BLOCKED ALARM. (B)(6) 2026 10:32:59 DOP114-980DOC_VER_BC: BATTERY FAILED ALARM CUSTOMER REPORTED RECEIVING A BATTERY FAILED ALARM. (B)(6) 2026 10:32:59 DOP114-980DOC_VER_BC: GENERAL DOCUMENTATION THE CUSTOMER CALLED FOR AN ISSUE NOT COVERED BY EXISTING TROUBLESHOOTING GUIDES. REFER TO THE EVENT DESCRIPTION FOR MORE DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664186 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 49 YR Male