BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PERSONAL MMT-7333

    MDR report key: 18463342 · Received January 8, 2024

    Report

    Report Number
    2032227-2024-103376
    Event Type
    Malfunction
    Date Received
    January 8, 2024
    Date of Event
    November 2, 2023
    Report Date
    April 16, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    "AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING CP APP WITH 3.2.0 INSTALLED ON SAMSUNG GALAXY S10 E (V.12) WITH MMT-1886 PUMP (SOFTWARE VERSION 6.7W) WAS CONDUCTED AND CONFIRMED THE ISSUE IS REPRODUCED. WE HAVE OBSERVED THAT WE ARE NOT RECEIVING PUSH NOTIFICATION AFTER UPGRADING CP APP FROM PREVIOUS VERSION TO 3.2.0. THE SOFTWARE FAILED TO MEET THE SPECIFIED REQUIREMENTS AND PERFORMANCE EXPECTATIONS, (SRS DOC: 3205046): 3231264,3231266,3240471 AGILE DOC: 10948256DOC. WE CONDUCTED A THOROUGH INVESTIGATION AND FOUND THAT , WITH THE INTRODUCTION OF UDM IN VERSION 3.2.0, THE JSON STRUCTURE OF 'DISPLAY MESSAGE' RESPONSE OBJECTS HAVE TRANSFORMED. AS A RESULT, THE DATABASE-TO-APPLICATION (DBTOAPPNOTIFICATIONHISTORYENTITYMAPPER) MAPPER FAILS TO FETCH THE OBJECTS FROM THE DATABASE, CAUSING THEM TO FAIL TO LOAD ON THE HISTORY SCREEN. THIS ISSUE LEADS TO A CONTINUOUS LOADING SPINNER ON THE HISTORY SCREEN. THE ESF NUMBER THAT CORRESPONDS TO THE REPORTED ISSUE IS 4975798. 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. UNFOLLOW AND THEN FOLLOW THE PATIENT AGAIN. 2. REINSTALL THE 3.2.0 APP. THE ISSUE WILL BE RESOLVED IN THE UPCOMING CP APPLICATION 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

    AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING CP APP WITH 3.2.0 INSTALLED ON SAMSUNG GALAXY S24 (V.14) WITH MMT-1886 PUMP (SOFTWARE VERSION 8.13.2) WAS CONDUCTED AND CONFIRMED THE ISSUE IS REPRODUCED. WE HAVE OBSERVED THAT WE ARE NOT RECEIVING PUSH NOTIFICATION AFTER UPGRADING CP APP FROM PREVIOUS VERSION TO 3.2.0. THE SOFTWARE FAILED TO MEET THE SPECIFIED REQUIREMENTS AND PERFORMANCE EXPECTATIONS, (SRS DOC: (B)(4): 3231264,3231266,3240471 AGILE DOC: (B)(4). WE CONDUCTED A THOROUGH INVESTIGATION AND FOUND THAT , WITH THE INTRODUCTION OF UDM IN VERSION 3.2.0, THE JSON STRUCTURE OF 'DISPLAY MESSAGE' RESPONSE OBJECTS HAVE TRANSFORMED. AS A RESULT, THE DATABASE-TO-APPLICATION (DBTOAPPNOTIFICATIONHISTORYENTITYMAPPER) MAPPER FAILS TO FETCH THE OBJECTS FROM THE DATABASE, CAUSING THEM TO FAIL TO LOAD ON THE HISTORY SCREEN. THIS ISSUE LEADS TO A CONTINUOUS LOADING SPINNER ON THE HISTORY SCREEN. THE ESF NUMBER THAT CORRESPONDS TO THE REPORTED ISSUE IS 4975798. 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. UPGRADE AN APPLICATION TO LATEST VERSION. THE ISSUE HAS BEEN RESOLVED IN LATEST BUILD. 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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER DID NOT RECEIVE NOTIFICATIONS FROM MINIMED MOBILE APP. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949962 CARELINK PERSONAL MMT-7333 SENSOR, GLUCOSE, INVASIVE MDS MEDTRONIC MINIMED MMT-7333

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Unknown