BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFTWR MMT-6122 FOTA IOS OUS/US

    MDR report key: 17709116 · Received September 8, 2023

    Report

    Report Number
    2032227-2023-269209
    Event Type
    Malfunction
    Date Received
    September 8, 2023
    Date of Event
    August 21, 2023
    Report Date
    October 29, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OUG
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    "AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING FOTA APP VERSION 1.3.3 INSTALLED ON IPHONE 12 MINI (OS 16.6) WITH MMT-1880 PUMP (SOFTWARE VERSION 9.11.5) WAS CONDUCTED AND CONFIRMED THE ISSUE IS NOT REPRODUCED. ONE ATTEMPT WAS PERFORMED TO REPRODUCE THE ISSUE. AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING FOTA APP VERSION 1.3.3 INSTALLED ON IPHONE 11 (OS 17 BETA) WITH MMT-1880 PUMP (SOFTWARE VERSION 8.11.3) 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 (B)(4) DOCUMENT (B)(4), VERSION G. AFTER INVESTIGATING AND TESTING, WE HAVE DETERMINED THAT THE FOTA APP MEETS ALL REQUIREMENTS, AND NO ISSUES WERE FOUND. TO ASSIST WITH THE RESOLUTION OF THE ISSUE, WE PROVIDED THE HELPLINE TEAM WITH THE FOLLOWING STEPS TO ENSURE THAT IT IS ADDRESSED EFFECTIVELY: 1. REMOVE MMM AND FOTA APPS FROM THE MOBILE DEVICE. 2. UNPAIR MOBILE DEVICE FROM PUMP: OPTIONS > UTILITIES > DEVICE OPTIONS > MANAGE DEVICES > SELECT ""MOBILE XXXXXX"" AND DELETE (OR DOUBLE CHECK THAT THE MOBILE DEVICE IS NOT DISPLAYED IN MANAGE DEVICES). 3. GO TO SETTINGS > BLUETOOTH ON THE IPHONE (NOT A QUICK SETTINGS). 4. UNPAIR THE PUMP FROM THE PAIRED DEVICES: TAP THE MORE INFO BUTTON > FORGET THIS DEVICE (OR DOUBLE CHECK THAT THE PUMP IS NOT DISPLAYED IN BLUETOOTH SETTINGS). 5. TURN OFF BLUETOOTH FOR A FEW SECONDS (NOT A QUICK SETTINGS). 6. TURN ON BLUETOOTH. 7. RESTART (REBOOT) THE MOBILE DEVICE. 8. INSTALL THE FOTA APP AND PROCEED WITH THE PUMP UPDATE. 9. IT IS CRUCIAL TO HIGHLIGHT TO THE USER: 9.1 WHILE THE ""PAIRING PUMP... PLEASE STAY ON THIS SCREEN UNTIL PAIRING IS COMPLETED."" AND ""PLEASE WAIT...TRYING TO RECONNECT TO PUMP."" MESSAGES ARE DISPLAYED, PLEASE DO NOT MOVE THE FOTA APP TO THE BACKGROUND. STAY ON THIS SCREEN UNTIL THE PAIRING PROCESS IS COMPLETE. 9.2PLEASE MAKE SURE TO FOLLOW THE INSTRUCTION ""KEEP YOUR MOBILE DEVICE NEAR THE PUMP"" WHEN USING THE FOTA APP. HELPLINE WAS ADVISED TO COMMUNICATE WITH THE CUSTOMER WITH THE PROVIDED STEPS FOR ISSUE RESOLVING. 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 WAS NOT ABLE TO PAIR THEIR DEVICES WITH THE MINIMED MOBILE APPLICATION. THE TROUBLESHOOTING WAS PERFORMED AND THE ISSUE WAS NOT RESOLVED. IT IS UNKNOWN IF THE CUSTOMER HAD CONTINUED TO USE THE DEVICE. THE PRODUCT WILL NOT BE RETURNED FOR THE PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457258 SFTWR MMT-6122 FOTA IOS OUS/US MEDICAL DEVICE DATA SYSTEM OUG MEDTRONIC MINIMED MMT-6122

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male