BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFTWR MMT-6121 FOTA ANDROID OUS/US

    MDR report key: 18472900 · Received January 9, 2024

    Report

    Report Number
    2032227-2024-103730
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    December 17, 2023
    Report Date
    February 13, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OUG
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER RECEIVES OOPS SOMETHING WENT WRONG IN FOTA APP (SAMSUNG GALAXY A51, ANDROID 13, APP VERSION 1.3.4). "THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN REQUIREMENT 3551323 DOCUMENT (B)(4), VERSION G. BASED ON THE FOTA APP LOGS THE CUSTOMER LAST TIME PERFORMED THE PUMP ELIGIBILITY CHECK ON (B)(6) 2023. AS A PACKAGE WAS NOT BEING ASSIGNED FOR THE (B)(6) AT THAT TIME THE TENEO SERVER RESPONDED WITH THE ""CANCEL"" COMMAND. RETRIEVING FROM TENEO CAUSED THE FOTA APPLICATION TO DISPLAY THE "" OOPS, SOMETHING WENT WRONG"" ERROR SCREEN. THE LAST RECEIVED COMMAND WAS DURING THE LAST TRY OF THE PUMP ELIGIBILITY CHECKING ON (B)(6) 2023: (B)(6) 2023 14:15:03,803 E [RXCACHEDTHREADSCHEDULER-13] BASETHROWABLEMAPPER HANDLE ERROR: COM.MEDTRONIC.MINIMED.NGPSDK.FIRMWAREUPDATE.BL.UNEXPECTEDBEHAVIOREXCEPTION: RECEIVED CANCEL COMMAND TWICE IN A ROW HOWEVER, FROM THE TENEO PACKAGE CONSOLE, THE PACKAGE WAS ""READY"" FOR THE (B)(6) PUMP ONLY ON (B)(6) 2023. THE HELPLINE WAS INFORMED THE CUSTOMER IS ELIGIBLE FOR THE PUMP UPGRADE. 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 OOPS, SOMETHING WENT WRONG AND THERE IS A PROBLEM COMMUNICATING TO OUR SERVERS MESSAGE WHEN UPDATER APP IS CHECKING FOR PUMP UPDATE. TROUBLESHOOTING WAS PERFORMED INSTALLED THE LATEST VERSION OF THE UPDATER APP AND MOVING PUMP AND MOBILE DEVICE CLOSER AND TRYING AGAIN , FORCE CLOSING AND RE-LAUNCHING THE APP ALSO DOESN'T RESOLVE THE ISSUE BUT THE CUSTOMER CAN ABLE TO ACCESS A WEB PAGE AND THE ISSUE WAS ESCALATED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL CONTINUE USING THE SOFTWARE AND THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597318 SFTWR MMT-6121 FOTA ANDROID OUS/US MEDICAL DEVICE DATA SYSTEM OUG MEDTRONIC MINIMED MMT-6121

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female