BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK CONNECT APP IOS

    MDR report key: 18604439 · Received January 30, 2024

    Report

    Report Number
    2032227-2024-117148
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Date of Event
    January 12, 2024
    Report Date
    April 3, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    PMA / PMN Number
    K151236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING CP APP WITH 3.2.0[1284] PROD OUS INSTALLED ON IPHONE 12 MINI(V17.0.3) WITH MMT-1885 PUMP (SOFTWARE VERSION 6.7V) WAS CONDUCTED AND CONFIRMED THE ISSUE IS REPRODUCED. WE HAVE OBSERVED THAT THE SG GRAPH AND PUSH NOTIFICATIONS ARE NOT VISIBLE ON THE PATIENT GRAPH SCREEN IN THE CP APP. THE SOFTWARE FAILED TO MEET THE SPECIFIED REQUIREMENTS AND PERFORMANCE EXPECTATIONS, (SRS DOC: (B)(4)): (B)(4) AGILE DOC: (B)(4). AFTER CONDUCTING A THOROUGH INVESTIGATION, WE FOUND TWO ISSUES. 1. THE DATE AND TIME SETTINGS ON THE PUMP DEVICE AND THE PATIENT DEVICE ARE NOT SYNCHRONIZED, WHICH IS CAUSING THE SG GRAPH TO NOT BE VISIBLE IN THE CP APP. 2. WITH THE INTRODUCTION OF UDM IN VERSION 3.2.0, THE JSON STRUCTURE OF 'DISPLAY MESSAGE' RESPONSE OBJECTS HAVE TRANSFORMED. AS A RESULT, THE DATABASE-TO-APPLICATION (DBTOAPPNOTIFICATIONHISTORYENTITYMAPPER) MAPPER FAILS TO FETCH THE OBJECTS FROM THE DATABASE, CAUSING THEM TO FAIL TO RECEIVE PUSH NOTIFICATIONS IN THE CP APPLICATION. THE ESF NUMBER THAT CORRESPONDS TO THE REPORTED ISSUES ARE (B)(4). TO ASSIST WITH THE RESOLUTION OF THE ISSUES, WE PROVIDED THE HELPLINE TEAM WITH THE FOLLOWING WORKAROUND TO ENSURE THAT IT IS ADDRESSED EFFECTIVELY: 1. FOR NO SG GRAPH ISSUE, PLEASE MAKE SURE THAT THE DATE AND TIME ARE SAME ON BOTH THE PUMP DEVICE AND THE PATIENT'S DEVICE, BY DOING THIS SG GRAPH WILL BE VISIBLE ON THE CP APP. YOU CAN SET THE DATE AND TIME ON THE PUMP DEVICE USING THE USER GUIDE. 2. FOR PUSH NOTIFICATION ISSUE, UNFOLLOW AND THEN FOLLOW THE PATIENT AGAIN OR REINSTALL THE APP. THE ISSUE WILL BE RESOLVED IN THE UPCOMING CP APPLICATION RELEASE/S. 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. 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 DOESN'T SUGGEST THAT THE MALFUNCTION WOULD CAUSE/CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED THE CARE LINK SYNCHRONIZATION ISSUE. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER CONTINUED THE USE OF THE MINIMED MOBILE APPLICATION AND IT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043230 CARELINK CONNECT APP IOS INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6112

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown