BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK CONNECT APP IOS

    MDR report key: 18089943 · Received November 8, 2023

    Report

    Report Number
    2032227-2023-299120
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    October 20, 2023
    Report Date
    December 19, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING THE CP APP WITH 3.2.0 INSTALLED ON IPHONE 13 MINI (V.16.6) WITH MMT-1885 PUMP (SOFTWARE VERSION 6.7W) WAS CONDUCTED AND THE ISSUE WAS REPRODUCED. WE HAVE OBSERVED THAT THE SG GRAPH ARE NOT VISIBLE ON THE PATIENT GRAPH SCREEN IN THE CP APP. ALSO WE HAVE OBSERVED THAT THE BASAL RATE IS 0.000 U/HR ON THE PATIENT GRAPH SCREEN. THE SOFTWARE FAILED TO MEET THE SPECIFIED REQUIREMENTS AND PERFORMANCE EXPECTATIONS, (SRS DOC: 3205046): 3212639,3258183 AGILE DOC: 10948256DOC.   AFTER CONDUCTING A THOROUGH INVESTIGATION, 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, WE INVESTIGATED ISSUE AND FOUND THAT THE ROOT CAUSE STEMS FROM THE CODE RESPONSIBLE FOR CONCEALING THE BASAL RATE DURING AUTO MODE IS 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 NOT BEEN ALTERED. THE ESF NUMBER THAT CORRESPONDS TO THE REPORTED ISSUE IS 4951894, 4972556. TO ASSIST WITH THE RESOLUTION OF THE SG GRAPH 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 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. CURRENTLY THERE IS NO WORK AROUND FOR BASAL RATE ISSUE. THE ISSUE WILL BE RESOLVED IN THE UPCOMING CARELINK 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. 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 MULTIPLE ISSUE WITH THE CARE LINK CONNECT FROM THE GRAPH, NOT SHOW OR THERE WAS CIRCLE OVER THE APPLICATION TO THE BASAL UNIT. TROUBLESHOOTING WAS PERFORMED AND THE ISSUE WAS NOT RESOLVED BY FORCE CLOSING AND RE-LAUNCHING THE APP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL CONTINUE THE USE OF THE APPLICATION AND DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1538052 CARELINK CONNECT APP IOS INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6112

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown