BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPHONE IOS APP: PUMP CONNECT

    MDR report key: 23121438 · Received September 23, 2025

    Report

    Report Number
    2032227-2025-266954
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    September 1, 2025
    Report Date
    December 26, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING THE MINIMED MOBILE APP (SOFTWARE VERSION 2.9.0) INSTALLED ON IPHONE 16 (IOS 18.3.1) WITH MMT1886 780G PUMP (SOFTWARE VER. 6.7W) WAS CONDUCTED AND CONFIRMED THE ISSUE WAS NOT REPRODUCED. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH EXPECTATIONS AS REFERENCED IN THE 'SW REQUIREMENT DOCUMENT' FIELD. MEDTRONIC UNABLE TO CONDUCT A THOROUGH INVESTIGATION DUE TO THE LACK OF DIAGNOSTIC LOGS NECESSARY TO PERFORM A COMPREHENSIVE ANALYSIS. I SEE A LOT OF CLOUD SDK TIME OUT WHICH INDICATES EITHER THE USER WAS NOT ON A STABLE NETWORK WHILE DOING INITIAL PAIRING OR THERE IS SOME ISSUE WITH CL. THERE IS NO SPECIFIC PUMPPHONE RELATED ISSUE THAT CAN CAUSE THE DISCONNECTION. STEPS TO RESOLVE THE REPORTED ISSUE WOULD INCLUDE: SETTINGS > GENERAL > IPHONE STORAGE > MINIMED MOBILE > DELETE APP. BY PERFORMING THIS STEP THE CUSTOMER WILL REMOVE ALL THE CACHED INFORMATION RELATED TO THE APP. REMOVE THE PUMP FROM THE IOS BLUETOOTH SETTINGS. RESTART THE PHONE. INSTALL THE MINIMED MOBILE APP. WAIT 10 MINUTES. ATTEMPT PAIRING AGAIN. IF THE ABOVE STEPS DIDN'T WORK, TRY SWITCHING THE INTERNET SOURCE (E.G. SWITCH FROM WIFI TO CELLULAR) AND REPEAT STEPS 14. ADDITIONALLY, IF THE CUSTOMER REACHES OUT AGAIN, PLEASE ASK THEM TO UPLOAD DIAGNOSTIC LOGS (MENU > ABOUT > DIAGNOSTIC LOGS > UPLOAD LOGS). THIS WILL HELP US GIVE MORE PERSONALIZED RECOMMENDATIONS. ISSUE STATUS: UNKNOWN. MEDTRONIC PROCEEDING TO CLOSE THIS TICKET. IF THE REPORTED ISSUE REOCCURS OR PERSISTS, MEDTRONIC KINDLY REQUEST YOU TO PROVIDE UPDATED INFORMATION SO MEDTRONIC CAN REOPEN THE TICKET. THIS WILL ALLOW US TO ADDRESS THE MATTER PROMPTLY AND EFFICIENTLY. 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 LOSS COMMUNICATION BETWEEN PUMP AND THE MOBILE APPLICATION. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-6102. TROUBLESHOOTING WAS PERFORMED AND IT WAS UNABLE TO RESOLVE WITH EXISTING TROUBLESHOOTING OR LABELED INSTRUCTIONS, ISSUE ESCALATED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. PRODUCT RETURN IS NOT APPLICABLE FOR NON- PHYSICAL DEVICE MMT-6102.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532563 SMARTPHONE IOS APP: PUMP CONNECT INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6102

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Unknown