BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPHONE IOS APP: PUMP CONNECT

    MDR report key: 17817174 · Received September 26, 2023

    Report

    Report Number
    2032227-2023-274539
    Event Type
    Malfunction
    Date Received
    September 26, 2023
    Date of Event
    August 30, 2023
    Report Date
    November 10, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER UNABLE TO UPLOAD TO CL, MINIMED MOBILE APP, 2.1.1, IPHONE 13, IOS 16.6. "AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING MINIMED MOBILE APP (SOFTWARE VERSION 2.1.0) INSTALLED ON IPHONE 14 PRO MAX (IOS 16.6) WITH MMT-1880 770G PUMP (SOFTWARE VER. 5.2A) WAS CONDUCTED AND CONFIRMED THE ISSUE WAS NOT REPRODUCED. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE (B)(4), VERSION C. AFTER CONDUCTING A THOROUGH INVESTIGATION, WE HAVE FOUND THAT THE MOST LIKELY REASON FOR MISSING AUTOMATIC CARELINK UPLOADS IS THAT THE MINIMED MOBILE APP WAS CLOSED AND NOT RUNNING IN BACKGROUND. AFTER ANALYZING THE PROVIDED DATA, IT WAS DETERMINED THAT THE ISSUE WAS ALREADY RESOLVED AND AUTOMATIC UPLOADS ARE HAPPENING SUCCESSFULLY SINCE AUG 31. TO ASSIST WITH THE RESOLUTION OF THE ISSUE OF MISSING AUTOMATIC UPLOADS, WE HAVE ADVISED TO MAKE SURE TO: 1. KEEP THE MINIMED MOBILE APP RUNNING (IT'S IMPORTANT NOT TO REMOVE IT FROM IOS APP SWITCHER MENU). 2. KEEP A ""SYNC TO CARELINK"" SWITCH ON THE SYNC TO CARELINK SCREEN TURNED ON. IF IT'S TURNED OFF AT ANY POINT OF TIME, AUTOMATIC UPLOADS WILL NOT HAPPEN. 3. HAVE A STABLE INTERNET CONNECTION DURING NIGHT TIME WHEN AUTOMATIC UPLOADS ARE USUALLY PERFORMED. 4. HAVE A PUMP CONNECTED TO THE PHONE. CARELINK UPLOAD WILL NOT HAPPEN IF THE PUMP IS NOT CONNECTED. 5. THE APP IS LOGGED IN TO CARELINK, ""CARELINK LOGGED OUT"" ICON IS NOT DISPLAYED ON THE HOME SCREEN. WE HAVE MADE ATTEMPTS TO CONTACT THE CUSTOMER/REP TO ADDRESS THE ISSUE, BUT WE HAVE BEEN UNABLE TO OBTAIN A RESPONSE. THEREFORE, WE HAVE INFORMED THE HELPLINE TEAM MEMBER THAT WE ARE PROCEEDING TO CLOSE THIS ISSUE. IF THE ISSUE PERSISTS, KINDLY CREATE A NEW ONE AND WE WILL TAKE SWIFT AND EFFICIENT ACTION TO ADDRESS IT. 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 RECEIVED BY MEDTRONIC INDICATED CUSTOMER COMPLAINED ABOUT PAIRING FAILED WITH MOBILE APPLICATION AND PUMP. TROUBLESHOOTING WAS PERFORMED AND NO INDICATION THAT ISSUE IS RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE TO USE THE DEVICE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972602 SMARTPHONE IOS APP: PUMP CONNECT INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6102

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Unknown