BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK CONNECT APP IOS

    MDR report key: 18082078 · Received November 7, 2023

    Report

    Report Number
    2032227-2023-298359
    Event Type
    Malfunction
    Date Received
    November 7, 2023
    Date of Event
    October 18, 2023
    Report Date
    September 10, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. INFORMATION HAS BEEN CORRECTED WHICH WAS NOT CORRECT IN THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN SECTION E1 WITH THIS REPORT.

    Additional Manufacturer Narrative · 0

    AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING THE CP APP WITH 3.2.0 INSTALLED ON IPHONE 8 PLUS (V14.4) WITH MMT-1885 PUMP (6.7W) WAS CONDUCTED AND THE ISSUE WAS REPRODUCED.WE HAVE OBSERVED THAT THE SG GRAPH IS NOT VISIBLE ON THE PATIENT GRAPH SCREEN IN THE CP APP.THE SOFTWARE FAILED TO MEET THE SPECIFIED REQUIREMENTS AND PERFORMANCE EXPECTATIONS, (SRS DOC: 3205046): 3213314,3213354,3214374,3212639,3258183 AGILE DOCS: 10948256DOC. WE FOUND TWO ISSUES IN OUR INVESTIGATION. FIRSTLY, 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 SECONDLY, THE ROOT CAUSE STEMS FROM THE CODE RESPONSIBLE FOR CONCEALING THE BASAL RATE DURING AUTO MODE NOT FUNCTIONING FOLLOWING THE TRANSITION TO UDM. WHILE THE SAME DEFAULT VALUES (0.000 RATE AND BASAL PATTERN 1) ARE TRANSMITTED TO CL AND CP IN AUTO MODE. THIS ISSUE DOESN'T APPEAR IN PRIOR EDITIONS OF CP, DESPITE THE FACT THAT THE CODE HAS YET TO BE ALTERED.THE ESF NUMBER THAT CORRESPONDS TO THE REPORTED ISSUE IS 4951894,4972556. TO ASSIST WITH THE RESOLUTION OF THE ISSUE, WE PROVIDED THE HELPLINE TEAM WITH THE FOLLOWING WORKAROUND TO ENSURE THAT IT IS ADDRESSED EFFECTIVELY: 1. PLEASE MAKE SURE THAT THE DATE AND TIME ARE THE SAME ON BOTH THE PUMP DEVICE AND THE PATIENT'S DEVICE, BY DOING THIS, THE 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. CURRENTLY THERE IS NO WORKAROUND FOR THE BASAL RATE ISSUE.THE ISSUE WILL BE RESOLVED IN THE UPCOMING CARELINK RELEASE/S. AFC: SOFTWARE ANOMALY - FA21AF. 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 WAS FACING AN ISSUE WITH THE CARELINK CONNECT APP. CUSTOMER STATED THAT SG GRAPH WAS NOT BEING DISPLAYED AFTER THE LAST UPDATE. TROUBLESHOOTING WAS PERFORMED AND THE ISSUE WAS NOT RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT IS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE TO USE THE APP OR NOT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352166 CARELINK CONNECT APP IOS INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6112

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown