BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-7020A ENLITE3 5PK US

    MDR report key: 22660931 · Received July 29, 2025

    Report

    Report Number
    2032227-2025-221453
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    September 27, 2023
    Report Date
    July 29, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    PMA / PMN Number
    P160007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 200 MG/DL WHILE SENSOR GLUCOSE VALUE WAS 50 MG/DL. THE CUSTOMER REPORTED NO ADVERSE EVENT. CUSTOMER MENTIONED THEY WERE IN THE INTENSIVE CARE UNIT WITH BLOOD GLUCOSE OF 800 MG/DL DUE TO PUMP NOT WORKING HOWEVER FOR THE SG V BG DIFFERENCE THIS WAS AFTER THAT EVENT, WHEN THEY WANTED TO ATTACH PUMP TO THE CUSTOMER. THE EVENT INVOLVED PRODUCT(S) MMT-7020A. THE SENSOR WAS WORN FOR FEWER THAN 4 DAYS. NO PRODUCT RETURN IS EXPECTED FOR MMT-7020A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49689 SENSOR MMT-7020A ENLITE3 5PK US AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7020A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown