BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPHONE IOS APP: PUMP CONNECT

    MDR report key: 22059051 · Received May 21, 2025

    Report

    Report Number
    2032227-2025-178640
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    April 24, 2025
    Report Date
    June 24, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    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. 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

    WE DID NOT ATTEMPT TO REPRODUCE THE ISSUE BECAUSE TESTING OR REPRODUCING IT WOULD NOT PROVIDE CONCLUSIVE RESULTS. INSTEAD THE ISSUE WAS INVESTIGATED THROUGH DATABASE APPLICATION LOGS. THE SOFTWARE SUPPORT TEAM'S THOROUGH INVESTIGATION OF THE DATABASE APPLICATION LOGS FOUND FAILED LOGIN EVENTS IN THE USER'S SSO LOGS. THIS SUGGESTS THAT THE USER WAS ENTERING INCORRECT CREDENTIALS OR FAILING THE MFA ATTEMPTS. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE ""SW REQUIREMENT DOC"" FIELD. ISSUE WAS CONFIRMED BY LOG ANALYSIS. TO ASSIST WITH THE RESOLUTION OF THE ISSUE, WE PROVIDED THE HELPLINE TEAM WITH THE FOLLOWING RECOMMENDATION TO ENSURE THAT IT IS ADDRESSED EFFECTIVELY: LOOKS LIKE THE PATIENT IS FAILING THE MFA AND GETTING LOCKED OUT. FIRST: I CAN CONFIRM THE PATIENT HAD MULTIPLE FAILED LOGIN ATTEMPTS. THE FAILED LOGIN ATTEMPTS ARE DUE TO INVALID CREDENTIALS BEING ENTERED. THE MOST RECENT LOGIN ATTEMPTS APPEAR TO BE FAILED. PLEASE HAVE THE PATIENT FOLLOW THE FOLLOWING STEPS: TRY LOGGING IN TO THE CARELINK WEBSITE ON INCOGNITO MODE. MAKE SURE THE USERNAME AND PASSWORD ARE ENTERED CORRECTLY. DISABLE ANY PASSWORD MANAGER OR AUTOFILL. IF THE PATIENT IS ABLE TO LOGIN TO THE WEBSITE, PLEASE HAVE THEM TRY LOGGING IN TO THE APP AGAIN. IF THE PATIENT IS NOT ABLE TO LOGIN THROUGH THE WEBSITE, THEN THEY SHOULD RESET THEIR PASSWORD. THEN TRY TO LOGIN THROUGH THE WEBSITE ONCE MORE. SECOND: THE PATIENT SHOULD CONFIRM THAT THEY DO NOT HAVE AUTOMATIC VERIFICATION ENABLED ON THEIR IPHONE. HERE ARE INSTRUCTIONS ON HOW TO ENABLE OR DISABLE AUTOMATIC VERIFICATION: HTTPS://SUPPORT.APPLE.COM/GUIDE/IPHONE/SIGN-IN-WITH-FEWER-CAPTCHA-CHALLENGES-IPH4F43A30C9/IOS. THIRD: THE PATIENT SHOULD CONFIRM THAT THEY ARE NOT BACKING UP THE APP TO ANY SERVICES LIKE ICLOUD, GOOGLE DRIVE ETC.. ALSO, AVOID THE USE OF AUTOFILL OR A PASSWORD MANAGER UNTIL THEY ARE ABLE TO LOGIN SUCCESSFULLY MANUALLY. FOURTH: AS A LAST RESORT. THE PATIENT COULD TRY DELETING THE APPLICATION AND WIPING THE APPLICATION CACHE AS A LAST RESORT. BUT THAT WILL CAUSE THE LOSS OF THE DATA THAT IS SAVED ON THE AFFECTED PHONE. HERE ARE THE INSTRUCTIONS FOR THAT PROCESS. SETTINGS > GENERAL > IPHONE STORAGE > MMM > DELETE APP. BY PERFORMING THIS STEP THE CUSTOMER WILL REMOVE ALL THE CACHED INFORMATION RELATED TO THE APP. IF (MINIMED MOBILE) DELETE THE PUMP FROM BLUETOOTH SETTINGS. UNINSTALL THE APPLICATION NORMALLY. RESTART THE PHONE. INSTALL THE MMM APP. WAIT 10 MINUTES. OPEN THE APP AND ATTEMPT PAIRING AGAIN. IF ISSUE IS NOT RESOLVED, WAIT 15 MINUTES AND TRY ALL STEPS AGAIN. THE MOST LIKELY ROOT CAUSE OF THIS ISSUE IS DUE TO USER ERROR. NO LOGS OR EVIDENCE OF A CARELINK FAULT OR ERROR FOUND. HELPLINE REPORTED THAT PATIENT COULD NOT BE REACHED FOR TROUBLESHOOTING. 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 BETWEEN PUMP AND THE MOBILE DEVICE AND LOG IN ISSUE. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-7333, MMT-6102. TROUBLESHOOTING WAS PERFORMED AND IT WAS UNABLE TO RESOLVE WITH EXISTING TROUBLESHOOTING OR LABELED INSTRUCTIONS, ISSUE ESCALATED FOR LOG IN ISSUE. IT WAS UNABLE TO COMPLETE TROUBLESHOOTING OR PROVIDE INSTRUCTIONS, INSUFFICIENT INFORMATION TO ESCALATE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-7333, MMT-6102.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81550 SMARTPHONE IOS APP: PUMP CONNECT INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6102

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female