BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPHONE ANDROID APP: PUMP CONNECT

    MDR report key: 22505630 · Received July 15, 2025

    Report

    Report Number
    2032227-2025-212793
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    June 16, 2025
    Report Date
    August 14, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    PMA / PMN Number
    K151236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH WAS NOT INCLUDED IN THE INITIAL REPORT. THE UPDATED INFORMATION HAS BEEN PROVIDED IN BELOW SECTIONS WITH THIS FOLLOW-UP REPORT. 1. SECTION B5 - UPDATED SUMMARY 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

    AN ATTEMPT TO REPRODUCE THE REPORTED ISSUE WAS NOT PERFORMED AS IT WAS CONFIRMED THROUGH PREVIOUS ISSUE REFERENCES. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH EXPECTATIONS AS REFERENCED IN THE 'SW REQUIREMENT DOCUMENT' FIELD. AFTER CONDUCTING A THOROUGH INVESTIGATION, WE HAVE FOUND THAT THE PAIRING IS FAILING DUE TO A SAKE KEY DECRYPTION FAILURE. THE SERVER RETURNED A PAYLOAD WITH INCORRECT DATA, WHICH USUALLY HAPPENS WHEN THE DEVICE FAILS THE PLAYINTEGRITY CHECK. THIS ERROR CODE WAS RETURNED: DEVICE_TYPE_NOT_SUPPORTED. WHEN A DEVICE FAILS THE PLAYINTEGRITY CHECK IT MEANS THAT IT IS FAILING GOOGLE'S SECURITY CHECK. THE ISSUE WAS CONFIRMED THROUGH LOG ANALYSIS. TO ASSIST WITH THE RESOLUTION OF THE ISSUE, WE PROVIDED THE HELPLINE TEAM WITH THE FOLLOWING STEPS TO ENSURE THAT IT IS ADDRESSED EFFECTIVELY: PROCEDURE TO UPDATE THE SECURITY PATCH MANUALLY BY USER: ENSURE THE PHONE IS CONNECTED TO A STABLE INTERNET CONNECTION AND IS PLUGGED IN TO CHARGE. OPEN PHONE SETTINGS: IN THE SETTINGS SEARCH BAR SEARCH FOR ÂSECURITY UPDATE. UNDER ÂSECURITY UPDATEÂ? YOU SHOULD SEE THE DATE OF THE LAST UPDATE. IF IT HAS BEEN MORE THAN A YEAR SINCE THE LAST UPDATE, YOU WILL NEED TO INSTALL THE LATEST SECURITY PATCH. CLICK ÂSECURITY UPDATEÂ? TO CHECK FOR THE LATEST PATCH TO INSTALL. IF YOUR PHONE IS ON AN OLDER ANDROID VERSION, IT MAY ALSO UPGRADE TO THE LATEST ANDROID VERSION IN ADDITION TO APPLYING THE SECURITY PATCH. APPLY THE UPDATE RESTART THE PHONE IF ONLY THE ANDROID OS (NOT SECURITY PATCH) WAS UPDATED AT STEP (E), REPEAT STEPS (A) TO (E) AGAIN, OTHERWISE, GO TO NEXT STEP. RESTART THE APP TO START PAIRING PROCESS AGAIN. IF ABOVE DO NOT WORK, PLEASE TRY BELOW: INSTALL ALL AVAILABLE OS AND GOOGLE PLAY SERVICES APP UPDATES FOR THE DEVICE AND TRY TO PAIR AGAIN. COULD YOU REACH THE PATIENT AND RECOMMEND THE FOLLOWING STEPS TO MAKE SURE PATIENTS PHONE HAS THE LATEST VERSION OF GOOGLE PLAY SERVICES OPEN ANDROID OS SETTINGS, FIND AND OPEN THE MENU APPS, CLICK ÂSEE ALL ¦ APPS, FIND AND OPEN ÂGOOGLE PLAY SERVICES, FIND AND OPEN ÂAPP DETAILS, UPDATE IF ALREADY INSTALLED OR INSTALL. COULD YOU PLEASE PROVIDE THE VERSION OF GOOGLE PLAY SERVICES CURRENTLY INSTALLED ON YOUR DEVICE? THIS INFORMATION WILL HELP US IDENTIFY THE ISSUE AND PROVIDE A RESOLUTION MORE EFFICIENTLY. OPEN SETTINGS > APPS > GOOGLE PLAY SERVICES. TAP APP DETAILS (THIS TAKES YOU TO THE GOOGLE PLAY STORE LISTING). YOU CAN SEE THE VERSION AT THE TOP OR UPDATE IT IF NEEDED. AFTER DOING FURTHER INVESTIGATION, WE FOUND THAT THE PATIENT¿S CURRENT DEVICE IS NO LONGER SUPPORTED BY THE MANUFACTURER OR BY GOOGLE, WHICH MEANS IT DOESN¿T PASS THE NECESSARY GOOGLE PLAY INTEGRITY CHECKS. COULD WE KINDLY ASK THE PATIENT TO TRY USING A DIFFERENT DEVICE? UNFORTUNATELY, THEIR CURRENT DEVICE IS NO LONGER SUPPORTED BY THE MANUFACTURER OR BY GOOGLE, WHICH MEANS IT DOESN¿T PASS THE NECESSARY GOOGLE PLAY INTEGRITY CHECKS. WE UNDERSTAND THIS MAY BE INCONVENIENT, AND WE TRULY APPRECIATE THEIR UNDERSTANDING AND PATIENCE AS WE WORK TOWARD THE BEST POSSIBLE EXPERIENCE FOR THEM. 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. 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

    UPDATED SUMMARY:- AS PER ADDITIONAL INFORMATION RECEIVED CUSTOMER REPORTED HAVING RECEIVED "DEVICE NOT COMPATIBLE" ERROR IN RELATION TO MINIMED MOBILE. SO EVENT SUBMITTED UNDER REGULATORY REPORT 2032227-2025-212793 IS NOT-REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED NO COMMUNICATION BETWEEN PUMP AND THE MOBILE APPLICATION AND UNSUPPPORTED ANDROID/IOS DEVICE. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-6101. TROUBLESHOOTING WAS PERFORMED FOR LOSS OF COMMUNICATION AND IT WAS UNABLE TO RESOLVE WITH EXISTING TROUBLESHOOTING OR LABELED INSTRUCTIONS, ISSUE ESCALATED. UNSUPPPORTED ANDROID/IOS DEVICE TROUBLESHOOTING WAS PERFORMED AND INSTRUCTIONS WERE PROVIDED TO RESOLVE THE ISSUE, NO ESCALATION REQUIRED. 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
    153619 SMARTPHONE ANDROID APP: PUMP CONNECT INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6101

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male