BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPHONE ANDROID APP: PUMP CONNECT

    MDR report key: 20479597 · Received October 18, 2024

    Report

    Report Number
    2032227-2024-256735
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Date of Event
    September 29, 2024
    Report Date
    February 2, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    PMA / PMN Number
    K151236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING THE MINIMED MOBILE APP (SOFTWARE VERSION 2.6.0) INSTALLED ON XIAOMI REDMI NOTE 13 PRO (ANDROID 14) WITH MMT-1886 780G PUMP (SOFTWARE VER. 6.5W) WAS CONDUCTED AND CONFIRMED THE ISSUE WAS NOT REPRODUCED. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE SOFTWARE REQUIREMENT AND SPECIFICATION DOCUMENT: (B)(4). AFTER CONDUCTING A THOROUGH 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. THE ISSUE WAS CONFIRMED. TO ASSIST WITH THE RESOLUTION OF THE ISSUE, WE PROVIDED THE HELPLINE TEAM WITH THE FOLLOWING STEPS TO ENSURE THAT IT IS ADDRESSED EFFECTIVELY: BASIC STEPS: TURN BLUETOOTH OFF, WAIT 30 SECONDS, TURN BLUETOOTH BACK ON WHEN ATTEMPTING TO PAIR, DO NOT LEAVE THE PAIRING SCREEN DURING THE PROGRESS SPINNER, AND RESPOND TO ANY PROMPTS THAT MAY APPEAR TRY TO PAIR THE PUMP AND DEVICE IN ANOTHER LOCATION, WITH A LOWER POTENTIAL LEVEL OF ELECTROMAGNETIC NOISE (COMMON SOURCES - ACTIVE WI-FI NETWORKS & BLUETOOTH CONNECTIONS NEARBY). ADVANCED STEPS: CLEAR DATA OF BLUETOOTH APP: SETTINGS, APPS, MANAGE APPS, FIND AND TAP ON BLUETOOTH APP, CLEAR DATA. RESET NETWORK SETTINGS: SETTINGS, MORE CONNECTIVITY OPTIONS, RESET WI-FI, MOBILE NETWORKS, AND BLUETOOTH, RESET SETTINGS, PIN/FINGERPRINT, OK UNINSTALL APP, RESTART PHONE, TURN BLUETOOTH OFF THEN ON, REINSTALL APP. REMOVE ALL OTHER PAIRINGS ON THE PHONE WITH OTHER BLUETOOTH DEVICES. STOP ANY APPS FROM RUNNING IN THE BACKGROUND THAT COULD INTERRUPT THE BLE CONNECTION ATTEMPT TO PAIR WITH ANOTHER DEVICE, IF THE PUMP IS ABLE TO PAIR WITH ANOTHER DEVICE I WOULD RECOMMEND A FACTORY RESET OF THE PHONE. IF THE PUMP IS UNABLE TO PAIR WITH ANOTHER DEVICE I WOULD RECOMMEND A PUMP REPLACEMENT - ASK THE PT TO UPDATE THE APP TO THE LATEST V2.7.0 AND TRY THE BELOW STEPS. - MAKE SURE USERS REMOVE PAIRED DEVICES FROM PHONE AND PUMP. - ALSO ENSURE THAT THERE ARE NO OTHER PAIRED DEVICES ON THE PHONE. - DELETE THE MINIMED MOBILE APP'S MEMORY CACHE IN THE ANDROID SETTINGS: SETTINGS, APPS, FIND MINIMED - MOBILE IN THE LIST OF APPS, STORAGE AND CACHE, CLEAR CACHE AND DATA. - DELETE THE APP, - RESTART THE PHONE, - REINSTALL MMM APP, - CHECK FOR ALL THE USUAL CONNECTIVITY (INTERNET, BLUETOOTH ON, ETC.) - START THE PAIRING PROCESS FROM SCRATCH. 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 FROM 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. THE CUSTOMER WILL DISCONTINUE USING THE APPLICATION. NO PRODUCT RETURN IS REQUIRED FOR MMT-6101.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2208928 SMARTPHONE ANDROID APP: PUMP CONNECT INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6101

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Unknown