SMARTPHONE ANDROID APP: PUMP CONNECT
Report
- Report Number
- 2032227-2025-249865
- Event Type
- Malfunction
- Date Received
- September 2, 2025
- Date of Event
- August 6, 2025
- Report Date
- October 18, 2025
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- PKU
- PMA / PMN Number
- K151236
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- 003
Narratives
AN ATTEMPT TO REPRODUCE THE REPORTED EVENT WITH THE MINIMED MOBILE APP (SOFTWARE VERSION 2.9.0) INSTALLED ON MOTOROLA MOTO G POWER (ANDROID 15) WITH MMT1886 780G PUMP (SOFTWARE VERSION 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. FROM THE ANALYTIC LOGS WE SEE THE INITIAL PAIRING PROCESS WAS COMPLETED SUCCESSFULLY. AFTER THE DEVICE SUCCESSFULLY PAIRED, THE APP RAN INTO AN ISSUE. IT TRIED TO USE A BLUETOOTH FUNCTION, GET CHARACTERISTIC (UUID), BUT THE REQUIRED BLUETOOTH GATT SERVICE WASN'T SET UP PROPERLY OR WASN'T AVAILABLE AT THE TIME. ESSENTIALLY, WHEN THE MMM APP REQUESTED THE GATT DIS SERVICE THE PHONE RETURNED NULL. ISSUE IS NOT CONFIRMED. WE KINDLY ASK THAT YOU TRY USING A DIFFERENT PHONE, ONLY IF ONE IS AVAILABLE EITHER ANDROID OR IOS, WITH A PREFERENCE FOR IOS IF POSSIBLE UNTIL WE FIND A SOLUTION. WE APOLOGIZE FOR ANY INCONVENIENCE THIS MAY CAUSE AND GREATLY APPRECIATE YOUR PATIENCE AND UNDERSTANDING AS WE WORK TO RESOLVE THIS 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.
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED PAIRING FAILED BETWEEN PUMP AND THE MOBILE APPLICATION. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-6101. 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-6101.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 240041 | SMARTPHONE ANDROID APP: PUMP CONNECT | INSULIN PUMP SECONDARY DISPLAY | PKU | MEDTRONIC MINIMED | MMT-6101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Unknown |