BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPHONE ANDROID APP: PUMP CONNECT

    MDR report key: 15731556 · Received November 4, 2022

    Report

    Report Number
    2032227-2022-355761
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    August 22, 2022
    Report Date
    November 5, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING MOBILE DEVICE MOTOROLA MOTO G9 PLUS (ANDROID 11), MINIMED MOBILE APP (1.3.0) WITH 770G MMT-1880 PUMP (SOFTWARE VERSION 5.3A) WAS MADE AND THE CONNECTION (MORE THAN 10 ATTEMPTS) WAS SUCCESSFULLY ESTABLISHED. HENCE, THE ISSUE WAS NOT REPRODUCED. FROM THE APP LOG ANALYSIS WE FOUND THAT THE REASON FOR FAILED PAIRING ATTEMPTS IS A LOSS OF BONDING. ANALYSIS FROM THE PUMP TEAM SHOWED THERE ARE AUTHENTICATION FAILURES ON THE PUMP SIDE DURING THE PAIRING. THE LATEST LOGS SHOW A LOT OF SUPERVISOR_TIMEOUT ERRORS. IN ADDITION, THE MOST LIKELY CAUSE OF THE DISCONNECT IS RELATED TO THE SUPERVISOR TIMEOUT ERROR WHICH CAN BE CAUSED BY THE FOLLOWING: ANDROID DEVICE. BLUETOOTH STACK IMPLEMENTATION FEATURES HELPLINE WERE PROVIDE TROUBLESHOOTING STEPS BELOW. CUSTOMER DID NOT RESPOND AND THE TICKET WAS CLOSED. REMOVE THE PHONE FROM THE LIST OF ASSOCIATED DEVICES (THE PUMP). DELETE THE MMM APP. CLEAN DATA OF BLUETOOTH APP: SETTINGS - APPS - SEE ALL - TAP 3 DOT MENU IN TOP RIGHT CORNER- SELECT SHOW SYSTEM - FIND AND TAP ON BLUETOOTH APP - STORAGE & CACHE- CLEAR STORAGE RESET NETWORK SETTINGS: SETTINGS -> SYSTEM ->ADVANCED -> RESET OPTIONS -> RESET NETWORK SETTINGS. RESET WI-FI, MOBILE & BLUETOOTH RESTART THE DEVICE. INSTALL THE MMM APP. TURN OFF BATTERY OPTIMIZATION FOR THE MMM APP: LONG TAP ON THE MMM APP ICON - TAP APP INFO POPUP) - ADVANCED - BATTERY - BATTERY OPTIMIZATION- TAP ON "NOT OPTIMIZED" DROPDOWN, SELECT ALL APPS - FIND AND TAP ON MINIMED MOBILE APP - SELECT DON'T OPTIMIZE & PRESS DONE. PAIR PUMP AND DEVICE, DO NOT LEAVE THE PAIRING SCREEN DURING THE PAIRING PROCESS. 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

    ¿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, 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.

    Description of Event or Problem · 0

    ISSUE HAS BEEN RESOLVED. HENCE THE CASE WAS NOT REPORTABLE.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT CUSTOMER WAS NOT ABLE TO PAIR THE INSULIN PUMP WITH MOBILE DEVICE. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED PAIRING WAS NOT SUCCESSFUL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522478 SMARTPHONE ANDROID APP: PUMP CONNECT INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6101

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female