BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-7040C5 GUARDIAN4 5PK OUS 5

    MDR report key: 22801250 · Received August 13, 2025

    Report

    Report Number
    2032227-2025-235239
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    October 26, 2023
    Report Date
    August 13, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000020763000737249
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. 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. 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 13.4 MMOL/L WHILE SENSOR GLUCOSE VALUE WAS 4.4 MMOL/L. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-7040C5. THE SENSOR WAS WORN FOR 4 DAYS. CUSTOMER DECLINED TO REVIEW. USER HAD 3 SENSORS WITH ISSUES BUT ONLY ONE HAD SG V BG ISSUES. USER ALSO GOT A SENSOR UPDATING AND CHANGE SENSOR ALERT AFTER THE SG V BG DIFFERENCE. NO TAPE ISSUES WITH THE SENSOR. 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-7040C5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686954 SENSOR MMT-7040C5 GUARDIAN4 5PK OUS 5 AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-7040C5 HG7BC9G 000020763000737249

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Unknown