BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPHONE IOS APP: PUMP CONNECT

    MDR report key: 21591481 · Received March 13, 2025

    Report

    Report Number
    2032227-2025-134654
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 12, 2025
    Report Date
    March 13, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. AN ATTEMPT TO REPRODUCE THE REPORTED ISSUE WAS NOT PERFORMED AS IT WAS CONFIRMED THROUGH PREVIOUS ISSUE REFERENCES. THE SOFTWARE DID NOT SUCCESSFULLY ADHERE TO THE SPECIFIED REQUIREMENTS AND DID NOT PERFORM IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE (B)(4). AFTER CONDUCTING A THOROUGH INVESTIGATION, WE HAVE FOUND THAT THE REASON FOR THE REPORTED BEHAVIOR IS A KNOWN IOS DEFECT RESULTING IN A "DEVICE NOT FOUND" MESSAGE ON THE PUMP. THE ESF NUMBER THAT CORRESPONDS TO THE REPORTED ISSUE IS: (B)(4). TO ASSIST WITH THE RESOLUTION OF THE ISSUE, WE PROVIDED HELPLINE TEAM WITH THE FOLLOWING STEP TO ENSURE THAT IT IS ADDRESSED EFFECTIVELY: PLEASE TRY RESETTING THE BLUETOOTH CACHE AND RE-PAIRING WITH THE PUMP USING THE FOLLOWING STEPS: 1. LEAVE THE PUMP PAIRING SCREEN IN THE MINIMED MOBILE APP IF IT ACTIVE. 2. REMOVE THE PUMP FROM THE IOS BLUETOOTH SETTINGS (SETTINGS > BLUETOOTH > PUMP XXXXXXXX > FORGET THIS DEVICE). 3. REMOVE THE MOBILE DEVICE FROM THE PUMP. 4. TURN BLUETOOTH OFF FROM THE IOS SETTINGS APP (SETTINGS > BLUETOOTH). 5. WAIT 5 MINUTES. THIS WAIT IS NEEDED TO ALLOW THE IOS TO RESET THE BLUETOOTH CACHE. 6. TURN BLUETOOTH BACK ON. 7. NAVIGATE TO THE PUMP PAIRING SCREEN IN THE MINIMED MOBILE APP. 8. ATTEMPT PAIRING WITH THE PUMP IF THE PREVIOUS STEPS DID NOT WORK, PLEASE TRY RESTARTING YOUR MOBILE DEVICE AND RE-PAIRING WITH THE PUMP USING THE FOLLOWING STEPS: 1. LEAVE THE PUMP PAIRING SCREEN IN THE MINIMED MOBILE APP IF IT ACTIVE. 2. REMOVE THE PUMP FROM THE IOS BLUETOOTH SETTINGS (SETTINGS > BLUETOOTH > PUMP XXXXXXXX > FORGET THIS DEVICE). 3. REMOVE THE MOBILE DEVICE FROM THE PUMP. 4. RESTART THE MOBILE DEVICE. 5. NAVIGATE TO THE PUMP PAIRING SCREEN IN THE MINIMED MOBILE APP. 6. ATTEMPT PAIRING WITH THE PUMP IF THE PREVIOUS STEPS DID NOT WORK, PLEASE TRY RE-INSTALLING THE MMM APP USING THE FOLLOWING STEPS: 1. REMOVE THE MINIMED MOBILE APP AND ALL THE APP DATA (SETTINGS > GENERAL > IPHONE STORAGE > MINIMED MOBILE > DELETE APP). 2. REMOVE THE PUMP FROM THE IOS BLUETOOTH SETTINGS (SETTINGS > BLUETOOTH > PUMP XXXXXXXX > FORGET THIS DEVICE). 3. REMOVE THE MOBILE DEVICE FROM THE PUMP. 4. INSTALL THE MINIMED MOBILE APP. 5. NAVIGATE TO THE PUMP PAIRING SCREEN IN THE MINIMED MOBILE APP. 6. ATTEMPT PAIRING WITH THE PUMP. THE HELPLINE HAS NOT PROVIDED FEEDBACK ON THE RECOMMENDED STEPS AND WHETHER THE ISSUE HAS BEEN RESOLVED. 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 REPORTED A LOSS OF COMMUNICATION BETWEEN THE INSULIN PUMP AND MOBILE APPLICATION.  THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT MMT-6102. TROUBLESHOOTING WAS PERFORMED. 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-6102.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804067 SMARTPHONE IOS APP: PUMP CONNECT INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6102

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Unknown