BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK CONNECT APP ANDROID

    MDR report key: 17278440 · Received July 7, 2023

    Report

    Report Number
    2032227-2023-233131
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 12, 2023
    Report Date
    September 26, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    "AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING THE CP APP WITH 3.1.0 INSTALLED ON GOOGLE PIXEL 4A, (V13.0.0) WITH MMT-1812 PUMP (SOFTWARE VERSION 5.3F) WAS CONDUCTED, AND CONFIRMED THE ISSUE IS NOT REPRODUCED. THE SOFTWARE MET THE SPECIFIED REQUIREMENTS AND PERFORMED AS EXPECTED ACCORDING TO THE SOFTWARE REQUIREMENTS DOCUMENT (SRS DOC: (B)(4) ): 3212619: THE CP APP SW SHALL INDICATE IF THE PATIENT DEVICE HAS THE PLGM/LGS FEATURE ON BUT IS IN THE REFRACTORY PERIOD AS COMMUNICATED BY CARELINK. 3212625: THE CP APP SW SHALL INDICATE IF THE PATIENT DEVICE HAS THE PLGM/LGS FEATURE ON, BUT DELIVERY IS CURRENTLY SUSPENDED AS COMMUNICATED BY CARELINK. 3212623: THE CP APP SW SHALL INDICATE IF THE PATIENT DEVICE HAS THE PLGM/LGS FEATURE ON, AND DELIVERY IS CURRENTLY NOT SUSPENDED AS COMMUNICATED BY CARELINK, AGILE DOC: (B)(4).. AFTER INVESTIGATING THE TICKET DESCRIPTION AND PERFORMING TESTING BASED ON IT, WE HAVE DETERMINED THAT THE CP APP MEETS ALL REQUIREMENTS, AND NO ISSUES WERE FOUND. THE RESOLUTION STEPS NEED TO BE SET ON THE PUMP WHICH ARE AS FOLLOWS: 1. SET AUTOMODESHIELDSTATE AS AUTO BASAL, 2. SET PLGMLGSSTATE AS FEATURE_OFF 3. SET PUMP DELIVERY SUSPEND STATE AS FALSE. HELPLINE WAS ADVISED ON THE ISSUE TO PROVIDE THE ABOVE DETAILS AND CREATE A NEW SVN FOR THE CONCERNED PRODUCT IF THE ISSUE STILL PERSISTS. 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 THAT THE CUSTOMER'S CARE PARTNERS CANNOT SEE THE GREEN BAND ON THE SENSOR GRAPH. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT TO OPEN THE APPLICATION IT WAS LOADING FOR A LONG TIME. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE THE USE OF THE APPLICATION OR NOT AND THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497234 CARELINK CONNECT APP ANDROID INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6111

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Unknown