BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-7040MA GS3 5PK US

    MDR report key: 22088622 · Received May 27, 2025

    Report

    Report Number
    2032227-2025-182053
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    April 29, 2025
    Report Date
    July 13, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL REVIEW OF THE EVENT SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. 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 TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA DUE TO DISCREPANCY IN BLOOD GLUCOSE AND SENSOR GLUCOSE. THE CUSTOMER RECEIVED CALIBRATION NOT ACCEPTED ALERT AND THE TAPE OF THE SENSOR WAS NOT STICKING. THE EVENT INVOLVED PRODUCT(S) MMT-7040MA. TROUBLESHOOTING WAS PERFORMED AND BLOOD GLUCOSE WAS 163 MG/DL AND SENSOR GLUCOSE WAS 77 MG/DL AND THE DIFFERENCE BETWEEN BLOOD GLUCOSE AND SENSOR GLUCOSE WAS NOT WITHIN THE RANGE. CUSTOMER WAS EXPLAINED SENSOR MAY HAVE NO LONGER BEEN RESPONDING TO GLUCOSE CHANGES AND EXPLAINED POSSIBLE CAUSES. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. PRODUCT RETURN FOR MMT-7040MA IS NOT EXPECTED.

    Description of Event or Problem · 0

    UPDATED SUMMARY: THE DIFFERENCE BETWEEN BLOOD GLUCOSE AND SENSOR GLUCOSE WAS WITHIN THE ACCEPTABLE RANGE. SO, THE EVENT SUBMITTED UNDER REGULATORY REPORT NUMBER 2032227-2025-182053 IS NOT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729955 SENSOR MMT-7040MA GS3 5PK US AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7040MA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female