SFTWR MMT-6121 FOTA ANDROID OUS/US
Report
- Report Number
- 2032227-2023-259665
- Event Type
- Malfunction
- Date Received
- August 23, 2023
- Date of Event
- August 3, 2023
- Report Date
- December 8, 2023
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OUG
- PMA / PMN Number
- P160017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- 003
Narratives
PATIENT PUMP IS NOT PAIRING TO FOTA APP (SAMSUNG GALAXY A14, ANDROID 13, APP VERSION 1.3.1) "AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING FOTA APP VERSION 1.3.1 INSTALLED ON SAMSUNG GALAXY S21 5G (OS 11) WITH MMT-1880 PUMP (FROM SOFTWARE VERSION 6.10.4) WAS CONDUCTED AND CONFIRMED THE ISSUE IS NOT REPRODUCED. ONE ATTEMPT WAS PERFORMED TO REPRODUCE THE ISSUE. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN REQUIREMENT 3551311 DOCUMENT (B)(4), VERSION G. WE WERE UNABLE TO CONDUCT A THOROUGH INVESTIGATION DUE TO MISSING LOGS NECESSARY TO PERFORM A COMPREHENSIVE ANALYSIS. WITHOUT ACCESS TO THE REQUIRED DATA, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE OF THE ISSUE. TO ASSIST WITH THE RESOLUTION OF THE ISSUE, WE PROVIDED THE HELPLINE TEAM WITH THE FOLLOWING STEPS TO ENSURE THAT IT IS ADDRESSED EFFECTIVELY: 1. PLEASE NOTE THAT THE USER MUST ACCEPT SYSTEM PAIRING POPUP REQUESTS ON THE APP SIDE. IN THE CASE OF ANDROID DEVICES, THERE MAY BE TWO IDENTICAL REQUESTS, BOTH OF WHICH MUST BE ACCEPTED. IF THE USER SKIPS THE SECOND REQUEST, IT COULD RESULT IN FAILED PAIRING. 2. PLEASE MAKE SURE TO UNPAIR THE MOBILE DEVICE FROM THE PUMP BEFORE STARTING THE APPLICATION. 3. DO NOT MOVE THE APP TO THE BACKGROUND DURING PAIRING BECAUSE SOME ACTIONS COULD BE SKIPPED ACCIDENTALLY. HELPLINE WAS ADVISED TO COMMUNICATE WITH THE CUSTOMER WITH PROVIDED STEPS FOR ISSUE RESOLVING. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
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, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING FOTA APP VERSION 1.3.1 INSTALLED ON SAMSUNG GALAXY S21 5G (OS 11) WITH MMT-1880 PUMP (FROM SOFTWARE VERSION 6.10.4) WAS CONDUCTED AND CONFIRMED THE ISSUE IS NOT REPRODUCED. ONE ATTEMPT WAS PERFORMED TO REPRODUCE THE ISSUE. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS. WE WERE UNABLE TO CONDUCT A THOROUGH INVESTIGATION DUE TO MISSING LOGS NECESSARY TO PERFORM A COMPREHENSIVE ANALYSIS. WITHOUT ACCESS TO THE REQUIRED DATA, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE OF THE ISSUE. TO ASSIST WITH THE RESOLUTION OF THE ISSUE, WE PROVIDED THE HELPLINE TEAM WITH THE FOLLOWING STEPS TO ENSURE THAT IT IS ADDRESSED EFFECTIVELY: 1. PLEASE NOTE THAT THE USER MUST ACCEPT SYSTEM PAIRING POPUP REQUESTS ON THE APP SIDE. IN THE CASE OF ANDROID DEVICES, THERE MAY BE TWO IDENTICAL REQUESTS, BOTH OF WHICH MUST BE ACCEPTED. IF THE USER SKIPS THE SECOND REQUEST, IT COULD RESULT IN FAILED PAIRING. 2. PLEASE MAKE SURE TO UNPAIR THE MOBILE DEVICE FROM THE PUMP BEFORE STARTING THE APPLICATION. 3. DO NOT MOVE THE APP TO THE BACKGROUND DURING PAIRING BECAUSE SOME ACTIONS COULD BE SKIPPED ACCIDENTALLY. HELPLINE WAS ADVISED TO COMMUNICATE WITH THE CUSTOMER WITH PROVIDED STEPS FOR ISSUE RESOLVING. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED PUMP WAS NOT CONNECTING TO THE MINIMED MOBILE APPLICATION. TROUBLESHOOTING WAS PERFORMED AND UPLOADING WAS SUCCESSFUL. THE PARING ISSUE COULD NOT BE RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE USING THE DEVICE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1483091 | SFTWR MMT-6121 FOTA ANDROID OUS/US | MEDICAL DEVICE DATA SYSTEM | OUG | MEDTRONIC MINIMED | MMT-6121 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female |