BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPHONE ANDROID APP: PUMP CONNECT

    MDR report key: 18585718 · Received January 26, 2024

    Report

    Report Number
    2032227-2024-115806
    Event Type
    Malfunction
    Date Received
    January 26, 2024
    Date of Event
    January 11, 2024
    Report Date
    March 26, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING MINIMED MOBILE APP (SOFTWARE VERSION 2.2.1) INSTALLED ON SAMSUNG GALAXY S21 (ANDROID 13) WITH MMT-1884 780G PUMP (SOFTWARE VER. 6.7U.3) WAS CONDUCTED AND CONFIRMED THE ISSUE WAS NOT REPRODUCED. THE SOFTWARE DID NOT SUCCESSFULLY ADHERE TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE DOCUMENT: (B)(4). AFTER CONDUCTING A THOROUGH INVESTIGATION, WE HAVE FOUND THAT THE SNAPSHOT UPLOAD IS FAILING DUE TO A PUMP DISCONNECTION DURING THE SNAPSHOT UPLOAD. THE PUMP AND PHONE APP MUST BE CONNECTED DURING THE PROCESS OF A SNAPSHOT UPLOAD SINCE THE APP ACTS AS A BRIDGE BETWEEN THE PUMP INFORMATION AND CARELINK. SINCE THE PUMP IS DISCONNECTED DURING THE PROCESS, THE SNAPSHOT FAILS TO UPLOAD TO CARELINK. THE FIRST ERROR WE SEE IN THE PATTERN IS A BLUETOOTH GATT OPERATION TIME OUT, MEANING THAT THE BLUETOOTH SESSION BETWEEN THE PUMP AND APP HAS NOT FINALIZED WITHIN 30 SECONDS, THUS CLOSING THE SESSION. THIS THEN CAUSES THE APP TO MANUALLY DISCONNECT THE PUMP AND TRY TO RECONNECT. IT WAS OBSERVED THAT THE PHONE AND APP WERE ABLE TO RECONNECT EVERY TIME AFTER THIS ERROR. THE NEXT ERROR IN THE PATTERN, WHICH IS THE ROOT CAUSE OF THE ISSUE, WAS THE GET_REPOSITORY_REQUEST_STATUS FAILING DUE TO A TRANSFER_SESSION_EXPIRED ERROR. THIS ERROR OCCURS IN ONE OF THE STEPS IN THE SNAPSHOT UPLOAD PROCESS. THIS ERROR IS CAUSED BY THE GET_REPOSITORY_REQUEST_STATUS OPCODE EXCEEDING ITS GIVEN TIMEOUT TIME OF 35 SECONDS. THIS SPECIFIC EXCHANGE DURING THE MANUAL SNAPSHOT FAILS, CAUSING THE ENTIRE SNAPSHOT UPLOAD TO FAIL. THE ESF NUMBER THAT CORRESPONDS TO THE REPORTED ISSUE IS: 5042576. TO ASSIST WITH THE RESOLUTION OF THE ISSUE, WE PROVIDED THE HELPLINE TEAM WITH THE FOLLOWING WORKAROUND TO ENSURE THAT IT IS ADDRESSED EFFECTIVELY: MAKE SURE THAT THE PHONE AND PUMP ARE NEXT TO EACH OTHER DURING THE PROCESS REMIND THE CUSTOMER THAT THE UPLOADS COULD LAST FOR 2 HOURS IF CUSTOMER HAS RECENTLY UPDATED THE PUMP TO 780G, DELETE THE UPDATER APPLICATION FROM THE PHONE DELETE AND REINSTALL THE MINIMED MOBILE APPLICATION ENSURE BOTH THE PHONE AND PUMP DO NOT HAVE ANY PAIRINGS MAKE SURE THAT THERE ARE NO OTHER APPS WHICH USING A BLUETOOTH CONNECTION ON PHONE UNPAIR AND REPAIRING PUMP AND APP SET MMM APP BATTERY USAGE TO UNRESTRICTED TURN OFF POWER SAVING DEFINE MMM APP AS A NEVER-SLEEP APP SWITCH ADAPTIVE BATTERY TO OFF RESET NETWORK SETTINGS CLEAR BLUETOOTH CACHE IF THE PREVIOUS STEPS HAVE FAILED, PLEASE WALK CUSTOMER THROUGH UPLOADING SNAPSHOTS THROUGH A PC THERE HAVE BEEN REPORTS THATS UPLOADING SNAPSHOTS THROUGH THE PC HAS RESOLVED THE ISSUE ON THE MMM APP. THE WORKAROUND PROVIDED ISN'T A DEFINITIVE SOLUTION TO RESOLVE ALL ISSUES, BUT IT CAN EFFECTIVELY ADDRESS SOME SPECIFIC ISSUES. THE ISSUES WILL BE ADDRESSED IN THE UPCOMING FEATURE RELEASES OF THE MINIMED MOBILE APPLICATION. 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

    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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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 THE MOBILE PHONE HAD NO LONGER CONNECTED TO THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED AND ADVISED TO REMOVE, AND UNPAIR THE APPLICATION, BLUETOOTH OFF AND THE DEVICE REBOOTED FOLLOWED BY BLUETOOTH ON, THE APPLICATION WAS DOWNLOADED; HOWEVER, THE PAIRING PROCESS FAILED. THE CUSTOMER UPLOADED DIAGNOSTIC LOGS SUCCESSFULLY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER CONTINUED THE USE OF THE APPLICATION AND IT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898936 SMARTPHONE ANDROID APP: PUMP CONNECT INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6101

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Unknown