BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFTWR MMT-6122 FOTA IOS OUS/US

    MDR report key: 18000933 · Received October 25, 2023

    Report

    Report Number
    2032227-2023-289697
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    October 3, 2023
    Report Date
    November 22, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OUG
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER UNABLE TO UPDATE PUMP, UNABLE TO PAIR, SERVER ERROR, UPDATER, 1.3.4, IPHONE 7, IOS 14.2. "AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING FOTA APP VERSION 1.3.4 INSTALLED ON IPHONE 11 (OS 17.0.2) WITH MMT-1884 PUMP (SOFTWARE VERSION 9.11.5) WAS CONDUCTED AND CONFIRMED THE ISSUE IS NOT REPRODUCED. ONE ATTEMPT WAS PERFORMED TO REPRODUCE THE ISSUE. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN REQUIREMENT 3551182 DOCUMENT D00459457, VERSION G. WE PERFORMED AN ANALYSIS BASED ON THE TICKET DESCRIPTION AND THE PROVIDED LOGS. THE ""OOPS, SOMETHING WENT WRONG"" SCREEN WAS DISPLAYED EACH TIME THE SAKE KEYS WERE RETRIEVED FROM THE TENEO SERVER. THE FOTA APP SHOULD DISPLAY THE ""OOPS, SOMETHING WENT WRONG"" SCREEN IN THE FOLLOWING CASES: 1. INTERNET CONNECTION ON THE CUSTOMER'S MOBILE DEVICE, 2. TENEO SERVER ISSUES (CONNECTION TIMEOUT, SERVER ERROR). TO ASSIST WITH THE RESOLUTION OF THE ISSUE, WE PROVIDED THE HELPLINE TEAM WITH THE FOLLOWING STEPS TO ENSURE THAT IT IS ADDRESSED EFFECTIVELY: BE SURE TO USE A STABLE INTERNET CONNECTION (WI-FI OR CELLULAR), PERFORM ONE MORE ATTEMPT OR TRY AFTER A FEW HOURS IF THE PROBLEM REPEATS. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    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, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED THAT THE PUMP WAS NOT CONNECTING TO THE MINIMED MOBILE APPLICATION. TROUBLESHOOTING WAS PERFORMED AND THE ISSUE COULD NOT BE RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE USING THE DEVICE AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675239 SFTWR MMT-6122 FOTA IOS OUS/US MEDICAL DEVICE DATA SYSTEM OUG MEDTRONIC MINIMED MMT-6122

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female