BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK CONNECT APP IOS

    MDR report key: 18693055 · Received February 13, 2024

    Report

    Report Number
    2032227-2024-124584
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    January 19, 2024
    Report Date
    March 11, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    PMA / PMN Number
    K151236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    "AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING THE CP APP WITH 3.2.0 [1284] PROD BUILD INSTALLED ON IPHONE 14 (16.5.1) WITH MMT-1885 PUMP (SOFTWARE VERSION 8.12.2) 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 AGILE DOCS: 10948256DOC. AFTER CONDUCTING A THOROUGH INVESTIGATION, WE FOUND THAT 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. THE ESF NUMBER THAT CORRESPONDS TO THE REPORTED ISSUE IS (B)(4). 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 SG GRAPH WILL BE VISIBLE ON THE CP APP. YOU CAN SET THE DATE AND TIME ON THE PUMP DEVICE USING THE USER GUIDE. THE ISSUE WILL BE RESOLVED IN THE UPCOMING CP APPLICATION RELEASE/S. AFC: SOFTWARE ANOMALY - FA21AF. 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

    SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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 WAS NOT ABLE TO SEE THE SENSOR GRAPH LINE UNRESPONSIVE. 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 DEVICE OR NOT. THE DEVICE WILL NOT BE RETURNED FOR PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765801 CARELINK CONNECT APP IOS INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6112

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown