BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN FOTA SFTWR

    MDR report key: 16476508 · Received March 3, 2023

    Report

    Report Number
    2032227-2023-166186
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Date of Event
    February 3, 2023
    Report Date
    December 21, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OUG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MMM CLINICAL 2.0.1 PARTICIPANT MUST MANUALLY UPLOAD SNAPSHOT DATA / SAMSUNG GALAXY S10+ ANDROID 10 (FCL004). "AN ATTEMPT TO REPRODUCE THE REPORTED EVENT WITH CLINICAL MINIMED MOBILE APP (SOFTWARE VERSION 2.0.1) ON SAMSUNG GALAXY S9 (ANDROID 10) WITH 780G PUMP (SOFTWARE VERSION 6.7U.3) WAS CONDUCTED AND CONFIRMED THE ISSUE WAS NOT REPRODUCED. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE BLE CONNECT IOS AND ANDROID MOBILE SOFTWARE REQUIREMENTS SPECIFICATIONS, 10938329DOC, REVISION H. AFTER CONDUCTING A THOROUGH INVESTIGATION, WE FOUND THAT THERE WERE DISCONNECTS HAPPENING BETWEEN THE PHONE AND THE PUMP FREQUENTLY. IN THE CASE WHERE THE PUMP WAS DISCONNECTED AND THE PHONE HAD INITIATED A SNAPSHOT UPLOAD, THE UPLOAD FAILED BECAUSE A CONNECTION IS REQUIRED BETWEEN THE PHONE AND PUMP IN ORDER TO PROCESS THE SNAPSHOT. A DIAGNOSTIC CODE ERROR OF 72 (PUMP OUT OF RANGE) WAS BEING THROWN FROM THE APP LOGS. THE DISCONNECTIONS WERE OBSERVED TO BE HAPPENING CLOSER TO NIGHTTIME WHEN THE PHONE AND PUMP WOULD BE IDLE FOR MANY HOURS. SOME ANDROID DEVICES HAVE A DOZE/BATTERY OPTIMIZATION MODE IN WHICH LONG-RUNNING OPERATIONS ARE DROPPED IN ORDER TO SAVE BATTERY. THE ESF NUMBER THAT CORRESPONDS TO THE REPORTED ISSUE IS: 4870632. TO ASSIST WITH THE RESOLUTION OF THE ISSUE, WE PROVIDED THE HELPLINE TEAM WITH THE FOLLOWING STEPS TO ENSURE THAT IT IS ADDRESSED EFFECTIVELY: TO DELETE PAIRING WITH THE PUMP ON THE PHONE. TO DELETE PAIRING WITH THE PHONE ON THE PUMP. TO KEEP THE PUMP NEAR THE PHONE WHEN SNAPSHOT IS UPLOADING. TO TURN OFF BATTERY OPTIMIZATION FOR THE MINIMED MOBILE APP. 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 HAD A COMMUNICATION ISSUE BETWEEN THE DEVICE AND SOFTWARE. CUSTOMER REPORTED DATA WERE UPLOADED AUTOMATICALLY. TROUBLESHOOTING WAS PERFORMED AND THE ISSUE WAS NOT RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058707 UNKNOWN FOTA SFTWR MEDICAL DEVICE DATA SYSTEM OUG MEDTRONIC MINIMED UNK_FOTASOFTWARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown