SMARTPHONE IOS APP: PUMP CONNECT
Report
- Report Number
- 2032227-2025-214069
- Event Type
- Malfunction
- Date Received
- July 16, 2025
- Date of Event
- June 24, 2025
- Report Date
- October 23, 2025
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- PKU
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH WAS NOT INCLUDED IN THE FIRST SUPPLEMENTAL REPORT 2032227-2025-214069-1. THE INFORMATION HAS BEEN PROVIDED IN SECTION H11 (ADDITIONAL INVESTIGATION SUMMARY) WITH THIS REPORT. 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 THE EXPECTATIONS SPECIFIED IN THE SOFTWARE REQUIREMENT AND SPECIFICATION DOCUMENT: ""SW REQUIREMENT DOC."" FROM APP LOG ANALYSIS, THE REASON FOR CONNECTIVITY PROBLEMS APPEARS TO BE DUE TO MISSING BONDING KEYS WHICH TYPICALLY CAUSE RECONNECTION AFTER PAIRING TO FAIL. THE ISSUE IS 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. THE HELPLINE HAS PROVIDED US WITH FEEDBACK REGARDING THE OUTCOME OF THE RESOLUTION STEPS IMPLEMENTED AND HAS CONFIRMED THE ISSUE HAS BEEN SUCCESSFULLY RESOLVED. 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 ITS 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 ITS 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 CONFIRMED WHETHER THE RECOMMENDED STEPS PROVIDED HAS RESOLVED THE ISSUE. 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.
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.
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 THE EXPECTATIONS SPECIFIED IN THE SOFTWARE REQUIREMENT AND SPECIFICATION DOCUMENT: ""SW REQUIREMENT DOC."". FROM APP LOG ANALYSIS, THE REASON FOR CONNECTIVITY PROBLEMS APPEARS TO BE DUE TO MISSING BONDING KEYS WHICH TYPICALLY CAUSE RECONNECTION AFTER PAIRING TO FAIL. THE ISSUE IS 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. THE HELPLINE HAS PROVIDED US WITH FEEDBACK REGARDING THE OUTCOME OF THE RESOLUTION STEPS IMPLEMENTED AND HAS CONFIRMED THE ISSUE HAS BEEN SUCCESSFULLY RESOLVED. 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 ITS 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 ITS 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 CONFIRMED WHETHER THE RECOMMENDED STEPS PROVIDED HAS RESOLVED THE ISSUE. 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.
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 THE EXPECTATIONS SPECIFIED IN THE SOFTWARE REQUIREMENT AND SPECIFICATION DOCUMENT: ""SW REQUIREMENT DOC."" FROM APP LOG ANALYSIS, THE REASON FOR CONNECTIVITY PROBLEMS APPEARS TO BE DUE TO MISSING BONDING KEYS WHICH TYPICALLY CAUSE RECONNECTION AFTER PAIRING TO FAIL. THE ISSUE IS 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. 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 ITS 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 ITS 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 CONFIRMED WHETHER THE RECOMMENDED STEPS PROVIDED HAS RESOLVED THE ISSUE. 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.
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED A CONNECTION ISSUE BETWEEN PUMP AND THE MOBILE DEVICE. 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. NO PRODUCT RETURN IS REQUIRED FOR MMT-6102.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 152333 | SMARTPHONE IOS APP: PUMP CONNECT | INSULIN PUMP SECONDARY DISPLAY | PKU | MEDTRONIC MINIMED | MMT-6102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Unknown |