BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPHONE ANDROID APP: PUMP CONNECT

    MDR report key: 18473647 · Received January 9, 2024

    Report

    Report Number
    2032227-2024-104175
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    December 18, 2023
    Report Date
    January 9, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTS DEVELOPER OPTIONS ENABLED PROMPT, MINIMED MOBILE 2.2, GALAXY S10, ANDROID 12 "AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING MINIMED MOBILE APP (SOFTWARE VERSION 2.2.0) USING VARIOUS CONFIGURATIONS WAS CONDUCTED AND CONFIRMED THE ISSUE WAS REPRODUCED ON FOLLOWING DEVICES: (B)(4). THE SOFTWARE DID NOT SUCCESSFULLY ADHERE TO THE SPECIFIED REQUIREMENTS NOR DID IT PERFORM IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN D00780504. AFTER CONDUCTING A THOROUGH INVESTIGATION, IT WAS FOUND THAT THE ISSUE IS BEING CAUSED BY A SECURITY LIBRARY INCORRECTLY FLAGGING THE DEVICE FOR USING A DEBUGGER TOOL. THE MMM APPLICATION SHOWS THE DEVELOPER OPTIONS SCREEN IN TWO SCENARIOS: 1. WHEN THE DEVELOPER OPTIONS IS TURNED ON IN THE ANDROID SETTINGS OR 2. WHEN THE ZSHIELD DEBUGGER DETECTION TOOL DETECTS THAT A DEBUGGER TOOL IS BEING USED ON THE DEVICE. IN CONTEXT OF THIS ISSUE, THE ZSHIELD DEBUGGER DETECTOR REPORTED THAT THE DEVICE WAS RUNNING A DEBUGGER ON THE PHONE, WHEN IN REALITY THERE WERE NONE. TO FIX THE ISSUE THE ZSHIELD VERSION WILL BE UPDATED FROM 2.95.0 TO 2.97.1. THE ESF NUMBER THAT CORRESPONDS TO THE REPORTED ISSUE IS: 4994218 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. OPEN SETTINGS 2. SCROLL DOWN AND TAP 'ABOUT THIS PHONE' 3. PRESS 'BUILD NUMBER' SEVEN TIMES 4. ENTER YOUR PIN (SET, IF ANY) AND DONE 5. GO TO INFO PHONE AND SCROLL DOWN TO DEVELOPER OPTIONS AND DISABLE 6. RETURN TO THE PHONE'S HOME SCREEN AND PRESS AND HOLD MINIMED MOBILE APP 7. GO TO ""I"" (APP INFO) 8. GO TO STORAGE 9. PRESS CLEAR DATA AND CLEAR CACHE IF ABOVE WORKAROUND DOES NOT WORK, THE ANTICIPATED FIX FOR THIS ISSUE IS SCHEDULED TO BE INCLUDED IN THE UPCOMING RELEASE OF MMM 2.2.1. 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 RECEIVED DEVELOPER OPTION ALERT IN MOBILE APP. TROUBLESHOOTING WAS PERFORMED BUT ISSUE COULD NOT BE RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN IF THE CUSTOMER WILL CONTINUE THE USE OF THE DEVICE OR NOT. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553983 SMARTPHONE ANDROID APP: PUMP CONNECT INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6101

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Unknown