SMARTPHONE ANDROID APP: PUMP CONNECT
Report
- Report Number
- 2032227-2023-243659
- Event Type
- Malfunction
- Date Received
- July 27, 2023
- Date of Event
- July 8, 2023
- Report Date
- November 22, 2023
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- PKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- 003
Narratives
CARELINK CONNECT DOES NOT LOAD PATIENT DATA (SAMSUNG A53, ANDROID 12, APP VERSION 2.3.1.) "AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING THE CP APP WITH 3.1.0 INSTALLED ON SAMSUNG S10 E, (V.12) WITH MMT-1812 PUMP (SOFTWARE VERSION 5.3F) WAS CONDUCTED AND CONFIRMED THE ISSUE IS NOT REPRODUCED. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE DOCUMENT (SRS DOC: 3205046): 3213347: THE CP APP SW SHALL DISPLAY THE LAST SG VALUE COMMUNICATED BY CARELINK, IF THERE IS ONE, IN THE SAME UNITS AS THE PATIENT DEVICE. 3212600: THE CP APP SW SHALL DISPLAY THE LAST SG RATE OF CHANGE COMMUNICATED BY CARELINK. 3212625: THE CP APP SW SHALL INDICATE IF THE PATIENT DEVICE HAS THE PLGM/LGS FEATURE ON BUT DELIVERY IS CURRENTLY SUSPENDED AS COMMUNICATED BY CARELINK. 3213310: THE CP APP SW SHALL DISPLAY UP TO 24 HOURS OF DATA PULLED FROM CARELINK ON THE GRAPH. AGILE DOC: 10948256DOC. BASED ON OUR THOROUGH INVESTIGATION, WE HAVE CONFIRMED THAT THE APPLICATION DATA FLOW IS FUNCTIONING PROPERLY. CUSTOMERS MOST LIKELY ADDRESSED THIS ISSUE DUE TO THE CARELINK OUTAGE OR RECEIVING POOR RESPONSES FROM CARELINK. WE HAVE INFORMED THE HELPLINE TEAM MEMBER THAT WE ARE PROCEEDING TO CLOSE THIS ISSUE. IF THE ISSUE PERSISTS, KINDLY CREATE A NEW SVN AND WE WILL TAKE SWIFT AND EFFICIENT ACTION TO ADDRESS IT. 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 THE CP APP WITH 3.1.0 INSTALLED ON SAMSUNG S10 E, (V.12) WITH MMT-1812 PUMP (SOFTWARE VERSION 5.3F) WAS CONDUCTED AND CONFIRMED THE ISSUE IS NOT REPRODUCED. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE DOCUMENT (SRS DOC: (B)(4)): (B)(4): THE CP APP SW SHALL DISPLAY THE LAST SG VALUE COMMUNICATED BY CARELINK, IF THERE IS ONE, IN THE SAME UNITS AS THE PATIENT DEVICE. (B)(4): THE CP APP SW SHALL DISPLAY THE LAST SG RATE OF CHANGE COMMUNICATED BY CARELINK. (B)(4): THE CP APP SW SHALL INDICATE IF THE PATIENT DEVICE HAS THE PLGM/LGS FEATURE ON BUT DELIVERY IS CURRENTLY SUSPENDED AS COMMUNICATED BY CARELINK. (B)(4): THE CP APP SW SHALL DISPLAY UP TO 24 HOURS OF DATA PULLED FROM CARELINK ON THE GRAPH. AGILE DOC: (B)(4). BASED ON OUR THOROUGH INVESTIGATION, WE HAVE CONFIRMED THAT THE APPLICATION DATA FLOW IS FUNCTIONING PROPERLY. CUSTOMERS MOST LIKELY ADDRESSED THIS ISSUE DUE TO THE CARELINK OUTAGE OR RECEIVING POOR RESPONSES FROM CARELINK. WE HAVE INFORMED THE HELPLINE TEAM MEMBER THAT WE ARE PROCEEDING TO CLOSE THIS ISSUE. IF THE ISSUE PERSISTS, KINDLY CREATE A NEW SVN AND WE WILL TAKE SWIFT AND EFFICIENT ACTION TO ADDRESS IT. 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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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'S CARELINK CONNECT APP DOES NOT LOAD. THE APP AUTOMATICALLY LOGS OUT AND THE CUSTOMER DID NOT GET ANY NOTIFICATIONS ABOUT THE GLUCOSE LEVELS. THE CUSTOMER HAD TO LOG IN AGAIN AND AGAIN TO PREVIEW THE GLUCOSE LEVELS. TROUBLESHOOTING WAS PERFORMED, CUSTOMER REINSTALLED THE APP TO GET THE ISSUE RESOLVED BUT IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. 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 |
|---|---|---|---|---|---|---|---|
| 671649 | SMARTPHONE ANDROID APP: PUMP CONNECT | INSULIN PUMP SECONDARY DISPLAY | PKU | MEDTRONIC MINIMED | MMT-6101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Unknown |