BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPHONE ANDROID APP: PUMP CONNECT

    MDR report key: 22684665 · Received August 1, 2025

    Report

    Report Number
    2032227-2025-223522
    Event Type
    Malfunction
    Date Received
    August 1, 2025
    Date of Event
    July 2, 2025
    Report Date
    September 28, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    PMA / PMN Number
    K151236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH WAS NOT INCLUDED IN THE INITIAL REPORT 2032227-2025-223522. THE INFORMATION HAS BEEN PROVIDED IN SECTION H11 (ADDITIONAL INVESTIGATION SUMMARY) WITH THIS REPORT. AN ATTEMPT TO REPRODUCE THE ISSUE WAS NOT PERFORMED AS THE ISSUE WAS CONFIRMED THROUGH PREVIOUS ISSUE REFERENCES. 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 THOROUGH INVESTIGATION WE HAVE FOUND THAT THE ISSUE IS DUE TO GATT CLIENT CONNECTION ERROR. THIS ERROR INDICATES A BLE LEVEL RELATED GENERIC ISSUE. THIS SPECIFIC ISSUE WAS OBSERVED AFTER THE PUMP HAD BONDED WITH THE PHONE BUT AFTER 2 MINUTES THE GATT CLIENT FAILED TO CONNECT, THUS FAILING THE ENTIRE PAIRING PROCESS. TO ASSIST WITH THE RESOLUTION OF THE ISSUE, WE PROVIDED HELPLINE TEAM WITH THE FOLLOWING STEPS. PLEASE CONNECT TO A STRONG NETWORK AND TRY TO PAIR. I WOULD RECOMMEND THESE GENERAL STEPS TO HELP RESOLVE THE ISSUE. 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: CLEAR STORAGE OR TO CLEAR CACHE. RESET NETWORK SETTINGS: SETTINGS, CONNECTION & SHARING, RESET WI-FI, MOBILE NETWORKS, AND BLUETOOTH, RESET SETTINGS. 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. THE ISSUE WAS CONFIRMED BY ANALYSIS OF THE LOGS THAT WERE COLLECTED FOR THE TIME OF THE EVENT. THE HELPLINE INFORMED US THAT THE ISSUE IS RESOLVED NOW AND NO FURTHER ANALYSIS REQUIRED. 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. AN ATTEMPT TO REPRODUCE THE ISSUE WAS NOT PERFORMED AS THE ISSUE WAS CONFIRMED THROUGH PREVIOUS ISSUE REFERENCES. 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 THOROUGH INVESTIGATION WE HAVE FOUND THAT THE ISSUE IS DUE TO GATT CLIENT CONNECTION ERROR. THIS ERROR INDICATES A BLE LEVEL RELATED GENERIC ISSUE. THIS SPECIFIC ISSUE WAS OBSERVED AFTER THE PUMP HAD BONDED WITH THE PHONE BUT AFTER 2 MINUTES THE GATT CLIENT FAILED TO CONNECT, THUS FAILING THE ENTIRE PAIRING PROCESS. TO ASSIST WITH THE RESOLUTION OF THE ISSUE, WE PROVIDED HELPLINE TEAM WITH THE FOLLOWING STEPS. PLEASE CONNECT TO A STRONG NETWORK AND TRY TO PAIR. I WOULD RECOMMEND THESE GENERAL STEPS TO HELP RESOLVE THE ISSUE. 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: CLEAR STORAGE OR TO CLEAR CACHE. RESET NETWORK SETTINGS: SETTINGS, CONNECTION & SHARING, RESET WI-FI, MOBILE NETWORKS, AND BLUETOOTH, RESET SETTINGS, 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. THE ISSUE WAS CONFIRMED BY ANALYSIS OF THE LOGS THAT WERE COLLECTED FOR THE TIME OF THE EVENT. THE HELPLINE INFORMED US THAT THE ISSUE IS RESOLVED NOW AND NO FURTHER ANALYSIS REQUIRED. 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 A PAIRING ISSUE BETWEEN PUMP AND MOBILE DEVICE. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-6101. TROUBLESHOOTING WAS PERFORMED AND IT WAS 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
    2238622 SMARTPHONE ANDROID APP: PUMP CONNECT INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6101

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male