BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR MMT-7040A GUARDIAN4 5PK US

    MDR report key: 23354522 · Received October 21, 2025

    Report

    Report Number
    2032227-2025-288001
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    January 5, 2024
    Report Date
    October 21, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW PER CAPA 686868. 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 35 MG/DL WHILE SENSOR GLUCOSE VALUE WAS 82 MG/DL. THEY ALSO EXPERIENCED SG V BG ON ANOTHER DAY WHERE BG WAS 32 MG/DL AND SG WAS 70 MG/DL. THE CUSTOMER REPORTED HYPOGLYCEMIA. TREATED THE 32 MG/DL WITH FOOD HOWEVER IT IS NOT CLEAR HOW THEY TREATED THE 35 MG/DL. USER STATED THEY ALSO FELL BUT NOT CLEAR WHAT DAY. WHEN ASKED IF THEY TAKE MEDICATION SUCH AS ACETAMINOPHEN, PARACETAMOL OR HYDROXYUREA (ALSO KNOWN AS HYDROXYCARBAMIDE) USER STATED YES, ADVIL, HYDROXYCHLOROQUINE AND TRAZODONE. CUSTOMER WAS ADVISED TAKING MEDICATIONS THAT CONTAIN PARACETAMOL OR ACETAMINOPHEN WHILE WEARING THE SENSOR MAY FALSELY RAISE SG READINGS AND THE LEVEL AND DURATION OF SENSOR INACCURACY DEPENDS ON HOW MUCH MEDICATION IS WORKING IN THE BODY AND WILL BE DIFFERENT FOR EACH PERSON. THE EVENT INVOLVED PRODUCT(S) MMT-7040A. THE SENSOR WAS WORN FOR 4 DAYS OR MORE. NO PRODUCT RETURN IS EXPECTED FOR MMT-7040A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1505181 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 65 YR Unknown Other FRN-MMT-342-RSVR, UNOMED INF SET