BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN FOTA SFTWR

    MDR report key: 22870156 · Received August 22, 2025

    Report

    Report Number
    2032227-2025-242438
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    July 29, 2025
    Report Date
    September 18, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OUG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS 2 OF 2 MEDWATCH REPORTS REGARDING THIS EVENT. 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 AND/OR ADDITIONAL INFORMATION RECEIVED 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 REPORTED THE CONNECTION ISSUES BETWEEN THE PUMP AND TRANSMITTER, AND THE ALERTS ARE NOT BEING SENT TO THE CONNECT APPLICATION. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-7841ZN, UNK_FOTASOFTWARE, MMT-1884L, AND MMT-7040A. TROUBLESHOOTING WAS NOT PERFORMED, AND IT WAS UNKNOWN WHETHER THE ISSUE WAS RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-7841ZN, UNK_FOTASOFTWARE, MMT-1884L, AND MMT-7040A.

    Description of Event or Problem · 0

    UPDATED SUMMARY: AS PER THE CASE NOTES AND ALLEGATIONS ON PRODUCT "MOBILE DEVICE APPLICATIONS" IS A NOT-REPORTABLE SCENARIO WITH REFERENCE TO OUR REPORTABILITY DECISION CRITERIA, SO HERE EVENT SUBMITTED UNDER REGULATORY REPORT 2032227-2025-242438 IS NOT-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1558030 UNKNOWN FOTA SFTWR MEDICAL DEVICE DATA SYSTEM OUG MEDTRONIC MINIMED UNK_FOTASOFTWARE

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female