BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN SENSOR 3

    MDR report key: 22974660 · Received September 4, 2025

    Report

    Report Number
    2032227-2025-252047
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    June 9, 2023
    Report Date
    September 4, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    002076300033698501
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW PER CAPA 686868. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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 240 MG/DL WHILE SENSOR GLUCOSE VALUE WAS 99 MG/DL. USER REPORTED OTHER SG V BG READINGS, BUT THEY WERE IN RANGE. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-7020LA. THE SENSOR WAS WORN FOR 4 DAYS OR MORE. SENSOR WAS SECURELY TAPED. 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-7020LA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320897 GUARDIAN SENSOR 3 AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-7020LA HG6GTHC 002076300033698501

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Unknown