BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPHONE ANDROID APP: PUMP CONNECT

    MDR report key: 21045991 · Received December 31, 2024

    Report

    Report Number
    2032227-2024-297841
    Event Type
    Malfunction
    Date Received
    December 31, 2024
    Date of Event
    December 11, 2024
    Report Date
    January 20, 2025
    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

    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: D00780504_E. CAUSE AND OR CONTRIBUTING FACTORS: 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 THOROUGH 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. STEPS TO RESOLVE OR RECOMMENDATION: 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 , DEVICES & SHARING, 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. THE HELPLINE HAS CONFIRMED THAT THIS ISSUE HAS BEEN RESOLVED WITH THE ABOVE STEPS. IN ADDITION, THE DEVELOPMENT TEAM IS ACTIVELY WORKING ON FINDING A PERMANENT FIX FOR THIS PAIRING ISSUE, AND FURTHER UPDATES WILL BE PROVIDED AS WE PROGRESS. 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

    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 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 NO COMMUNICATION PUMP TO MOBILE. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-6101. TROUBLESHOOTING WAS PERFORMED. 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
    1753089 SMARTPHONE ANDROID APP: PUMP CONNECT INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6101

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown