BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPHONE ANDROID APP: PUMP CONNECT

    MDR report key: 21753715 · Received April 2, 2025

    Report

    Report Number
    2032227-2025-147238
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    March 5, 2025
    Report Date
    April 2, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    PMA / PMN Number
    K151236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. WE HAVE ATTEMPTED TO REPRODUCE THE PAIRING FAILURE WITH A SUPERVISOR TIMEOUT ON THE XIAOMI 12, SAMSUNG GALAXY A35 AND GOOGLE PIXEL 8 PAIRED WITH A 780G PUMP RUNNING FIRMWARE VERSION 6.7. THE ISSUE OCCURRED CONSISTENTLY ON THESE DEVICES, DISPLAYING A ""DEVICE NOT FOUND"" MESSAGE ON THE PUMP. THE XIAOMI 12 WAS INITIALLY PAIRING SUCCESSFULLY ON ANDROID 13 BUT WAS RECENTLY UPDATED TO ANDROID 14 FOR TESTING. 100 PERCENT REPRODUCED. THE XIAOMI 13C SHOWED A 40% OCCURRENCE RATE OF THE ISSUE DURING TESTING, BUT THEY WERE UNABLE TO REPRODUCE IT ON THIS DEVICE IN THE LATEST ROUND OF TESTS THIS ISSUE HAS BEEN CONFIRMED THROUGH LOG ANALYSIS SHOWING SUPERVISOR TIMEOUT ERRORS. THE SOFTWARE DID NOT ADHERED TO THE SPECIFIED REQUIREMENTS AND FAILED TO PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE SOFTWARE REQUIREMENT AND SPECIFICATION DOCUMENT: (B)(4). AFTER CONDUCTING AN INITIAL INVESTIGATION, WE HAVE FOUND THAT THE MAIN REASON FOR FAILED CONNECTION ATTEMPTS WAS SUPERVISOR_TIMEOUT ERRORS THROWN BY OS, SUPERVISOR_TIMEOUT IN SUBSTANCE MEANS THAT THE PHONE DID NOT RECEIVE ANY MESSAGES FROM THE PUMP IN THE DEFINED PERIOD (APPROXIMATELY 30 SECONDS), THE MAIN POSSIBLE CAUSES FOR THAT ARE ERRORS IN DEVICE BLUETOOTH STACK IMPLEMENTATION OR HIGH LEVEL OF ELECTROMAGNETIC NOISE. AFTER THROUGH INVESTIGATION ON SUPERVISOR_TIMEOUT ERRORS, WE FOUND THAT DURING THE PAIRING PROCESS, THE MOBILE DEVICE SENT INCORRECT DATA IN RESPONSE TO A REQUEST FOR SPECIFIC BLUETOOTH INFORMATION (KNOWN AS GATT CHARACTERISTICS). THE ESF NUMBER THAT CORRESPONDS TO THE REPORTED ISSUE IS: 5192632. THIS ISSUE IS ABOUT THE PUMP BEING UNABLE TO PAIR WITH THE MINIMED MOBILE APP BECAUSE THE MOBILE DEVICE SENT AN INCORRECT RESPONSE WHEN TRYING TO CONNECT. TO ASSIST WITH THE RESOLUTION OF THE ISSUE, WE PROVIDED THE HELPLINE TEAM WITH THE FOLLOWING STEPS TO ENSURE THAT IT IS ADDRESSED EFFECTIVELY: DISABLE CROSS-DEVICE SERVICE IN THE PHONE 1. ON YOUR ANDROID DEVICE, OPEN SETTINGS . 2. TAP GOOGLE, GOOGLE DEVICES & SHARING (OR ALL SERVICES ON XIAOMI DEVICES), CROSS-DEVICE SERVICES. 1. OR SEARCH ¿¿CROSS-DEVICE FROM SETTINGS. 3. MAKE SURE USE CROSS-DEVICE SERVICES IS OFF OR DISABLED 4. FOLLOW THE INSTRUCTIONS IN MINIMED MOBILE APP TO ESTABLISH PAIRING BETWEEN PUMP AND PHONE NOTE: ONCE PAIRING IS COMPLETED, CROSS-DEVICE SERVICES CAN BE RE-ENABLED. HOWEVER, IF THE CONNECTION IS LOST AGAIN, YOU WILL NEED TO DISABLE THE CROSS-DEVICE FUNCTION TO RE-PAIR. WE HAVENT RECEIVED A RESPONSE CONFIRMING WHETHER THE RECOMMENDED STEPS RESOLVED THE ISSUE. AS A RESULT, WELL BE CLOSING THE TICKET. IF THE ISSUE PERSISTS, PLEASE LET US KNOW, AND WELL BE HAPPY TO REOPEN IT. 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 LOSS OF COMMUNICATION BETWEEN INSULIN PUMP AND MOBILE APPLICATION. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-6101. 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-6101.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2333993 SMARTPHONE ANDROID APP: PUMP CONNECT INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6101

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Unknown