BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK CONNECT APP ANDROID

    MDR report key: 18353877 · Received December 19, 2023

    Report

    Report Number
    2032227-2023-318356
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    June 26, 2023
    Report Date
    December 19, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    PMA / PMN Number
    K151236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    "AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING CP APP WITH 3.1.0 INSTALLED ON SAMSUNG S10 E, (V.12) WITH MMT-1885 PUMP (SOFTWARE VERSION 6.7V) WAS CONDUCTED AND CONFIRMED THE ISSUE IS NOT REPRODUCED. THE SOFTWARE MET THE SPECIFIED REQUIREMENTS AND PERFORMED AS EXPECTED ACCORDING TO THE SOFTWARE REQUIREMENTS DOCUMENT (SRS DOC: 3205046): 3231176: WHEN THE CP APP USER IS CONNECTED TO A PATIENT ACCOUNT THAT IS UNSUPPORTED BY THE CP APP, THE CP APP SW WILL DISPLAY THE UNSUPPORTED PATIENT DEVICE SCREEN AS THE DEFAULT HOME SCREEN. 3235566: THE CP APP SW WILL DISPLAY THE PATIENT STATUS AND SG GRAPH SCREEN AS THE DEFAULT SELECTED PATIENT RELATED SCREEN WITHIN THE PATIENT HOME SCREEN, AGILE DOC: 10948256DOC. AFTER CONDUCTING A THOROUGH INVESTIGATION, WE HAVE FOUND THAT THE CP APP IS NOT RECEIVING THE EXPECTED DATA FROM THE CARELINK SERVER. THE DATA SENT TO THE CAREPARTNER IS INCORRECTLY SETTING THE DEVICE FAMILY AS ""GUARDIAN."" THE EXPECTED DATA FOR CAREPARTNER FOLLOWING A MMM PATIENT SHOULD BE ""BLE OR BLE_X FAMILY"". HOWEVER, IN THIS CASE THE CP APP RECEIVES VALUE AS ""GUARDIAN"" DUE TO WHICH THE CAREPARTNER APP IS SHOWING AN UNSUPPORTED DEVICE SCREEN. THE ESF NUMBER THAT CORRESPONDS TO THE REPORTED ISSUE IS: 4883113 CURRENTLY, THERE IS NO WORKAROUND AVAILABLE TO ADDRESS THE ISSUE. WE HAVE INFORMED THE HELPLINE TEAM ABOUT THE SITUATION AND ARE ACTIVELY WORKING ON FINDING A SOLUTION/WORKAROUND. THE PROBLEM WILL BE RESOLVED IN THE UPCOMING CP3.2 APPLICATION. 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 AN UNEXPECTED UNSUPPORTED DEVICE SCREEN IN CARELINK CONNECT. TROUBLESHOOTING WAS PERFORMED BUT THE ISSUE WAS NOT RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE THE USE OF THE DEVICE. THE SAMD TECHNICAL ASSESSMENT WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164559 CARELINK CONNECT APP ANDROID INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6111

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Unknown