BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK CONNECT APP IOS

    MDR report key: 19317650 · Received May 15, 2024

    Report

    Report Number
    2032227-2024-169588
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    September 8, 2023
    Report Date
    August 22, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    PMA / PMN Number
    K151236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    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 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

    AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING CP APP WITH 3.1.1 INSTALLED ON IPAD AIR 5TH GEN (IOS 16.3.1) WITH MMT-1885 PUMP (SOFTWARE VERSION 6.7V) 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)): 3231176: WHEN THE CP APP USER IS CONNECTED TO A PATIENT ACCOUNT THAT IS UNSUPPORTED BY THE CP APP, THE CP APP SW WILL DISPLAY THE UNSUPPORTED PATIENT DEVICE SCREEN AS THE DEFAULT HOME SCREEN. 3235566: THE CP APP SW WILL DISPLAY THE PATIENT STATUS AND SG GRAPH SCREEN AS THE DEFAULT SELECTED PATIENT RELATED SCREEN WITHIN THE PATIENT HOME SCREEN, AGILE DOC: (B)(4). AFTER CONDUCTING A THOROUGH INVESTIGATION, WE HAVE FOUND THAT THE CP APP IS NOT RECEIVING THE EXPECTED DATA FROM THE CARELINK SERVER. THE DATA SENT TO THE CARE PARTNER IS INCORRECTLY SETTING THE DEVICE FAMILY AS ""GUARDIAN."" THE EXPECTED DATA FOR CARE PARTNER FOLLOWING A MMM PATIENT SHOULD BE ""BLE OR BLE_X FAMILY"". HOWEVER, IN THIS CASE THE CP APP RECEIVES VALUE AS ""GUARDIAN"" DUE TO WHICH THE CARE PARTNER APP IS SHOWING AN UNSUPPORTED DEVICE SCREEN. THE ESF NUMBER THAT CORRESPONDS TO THE REPORTED ISSUE IS: (B)(4). CURRENTLY, THERE IS NO WORKAROUND AVAILABLE TO ADDRESS THE ISSUE. WE HAVE INFORMED THE HELPLINE TEAM ABOUT THE SITUATION AND ARE ACTIVELY WORKING ON FINDING A SOLUTION/WORKAROUND. THE PROBLEM WILL BE RESOLVED IN THE UPCOMING APPLICATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED SOFTWARE ERROR. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-6112. UNABLE TO RESOLVE WITH EXISTING TROUBLESHOOTING OR LABELED INSTRUCTIONS, ISSUE ESCALATED NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-6112.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520015 CARELINK CONNECT APP IOS INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6112

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Unknown