MY DOSE COACH
Report
- Report Number
- 3010770778-2021-00005
- Event Type
- Injury
- Date Received
- May 5, 2021
- Report Date
- June 28, 2021
- Manufacturer
- SANOFI-AVENTIS DEUTSCHLAND GMBH
- Product Code
- NDC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
DEVICE MALFUNCTION [DEVICE MALFUNCTION] NO ADVERSE EVENT [NO ADVERSE EVENT] CASE NARRATIVE: INITIAL INFORMATION ALONG WITH A PRODUCT TECHNICAL COMPLAINT (PTC) RECEIVED ON 12-APR-2021 REGARDING AN UNSOLICITED VALID NON-SERIOUS MALFUNCTION CASE FROM AN OTHER HEALTH PROFESSIONAL IN UNITED STATES, INITIATED FOR MY DOSE COACH. BATCH NUMBER AND EXPIRATION DATE WERE UNKNOWN. GLOBAL PTC NUMBER: 100118387. THIS CASE INVOLVES A PATIENT OF UNKNOWN DEMOGRAPHICS REPORTED SINCE THE HEALTHCARE PROFESSIONAL (HCP) COULD NOT SEE THE DATA THAT CAME FROM PATIENT APPLICATION (DEVICE MALFUNCTION), WHILE USING THE MEDICAL DEVICE MY DOSE COACH. MY DOSE COACH HAS BEEN IDENTIFIED WITH A PRODUCT USE ISSUE. IT IS UNKNOWN IF THE PRODUCT WAS STORED OR USED PROPERLY. THE DEVICE WAS OPERATED BY OTHER. THE PATIENT'S MEDICAL HISTORY, PAST MEDICAL TREATMENT(S), VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. CONCOMITANT MEDICATION WAS NOT REPORTED. ON 08-APR-2021 (UNKNOWN LATENCY), AFTER THE INITIATION OF THE SUSPECT DEVICE, LOOKING AT THE PATIENT DATA FILE IT SEEMS THAT THE APP WAS NOT SYNCING OBSERVATIONS WITH THE SERVER. THERE ARE OTHER REQUESTS COMING IN FROM THE APP WHICH WERE BEING SUCCESSFULLY RESPONDED TO BY THE SERVER. THIS WAS AN INDICATION THAT THE APP TO SERVER COMMUNICATION WORKS FINE. THE LAST SUCCESSFUL REQUEST TO SYNC AN OBSERVATION WAS MADE ON APRIL 8TH. APP HAD NOT MADE A SYNC REQUEST SINCE THAT DATE. THE HCP WAS STILL ABLE TO UPDATE OR CHANGE THE PLAN FOR THE PATIENT (IF REQUIRED) AND THE DOSE RECOMMENDATIONS AND REMINDERS (WHICH DID NOT REQUIRE ANY COMMUNICATION WITH THE SERVER) WERE STILL WORKING AS EXPECTED FOR THE PATIENT. THERE IS NO NOTIFICATION TO THE HCP OR PATIENT THAT THE APP WAS NOT SYNCING OBSERVATION DATA. FURTHER INVESTIGATION SHOWS THAT THE SERVER WAS RECEIVING OBSERVATIONS FROM OTHER PATIENTS, SO THIS PROBLEM EXISTS ONLY WITH PATIENT 0003-0695-0939. TO REPRODUCE THE ISSUE, A CARE PLAN WAS CREATED ON THE TEST ENVIRONMENT WITH ALL THE SAME PARAMETERS OF THIS PATIENT. IT WAS SENT TO AN IOS TEST BUILD TO INVESTIGATE FURTHER. THE TEST FAILED TO RECREATE THE SCENARIO. ALL OBSERVATIONS LOGGED DURING THE TEST WERE SYNCED WITH THE SERVER AND WERE VISIBLE IN THE PORTAL. ROOT CAUSE - MULTIPLE CAUSES WERE HYPOTHESIZED AND TESTED TO SEE IF THEY WOULD REPRODUCE THE ISSUE. 1. SECURE STORAGE KEY CHAIN. THE APP WAS WITH THE WRONG STORAGE KEY CHAIN. THIS SHOWS A MESSAGE ON THE HOME SCREEN SAYING THAT THE PLAN HAD BE DEACTIVATED (THE DEFAULT ASSUMPTION IF THE APP COULD NOT CONFIRM THE USER OR PLAN ONLINE). RESTARTING WITH THE CORRECT KEY CHAIN RETURNED THE APP TO NORMAL. 2. BAD REQUEST. IF THE OBSERVATION REQUEST WAS NEVER SENT, IT WAS POSSIBLE THE REQUEST ITSELF FAILED TO BE CONSTRUCTED. THE APP WAS ALTERED TO PURPOSEFULLY FAIL TO CREATED THE ENDPOINT URL. THE APP WOULD JUST CRASH CONTINUOUSLY IN THAT CASE AS OBSERVATIONS WERE ATTEMPTED TO BE SENT. 3. CORRUPT DATABASE. IF THERE WERE SOME ISSUE ACCESSING THE DATA CONTEXT FOR EACH OBSERVATION IN THE DATABASE, THEIR FLAG FOR SYNCING MIGHT RESET AND NEVER BE SENT TO THE SERVER. IF THIS WERE THE CASE, NO EVENTS OF ANY KIND COULD BE UPDATED AND ONLY MISSED EVENTS WOULD APPEAR IN THE LOGBOOK. THE ROOT CAUSE WAS NOT DISCOVERED. SOFTWARE DEFECT - FAILED REQUIREMENT STATEMENT OF SAFETY THIS ISSUE COULD RESULT IN A DELAY OF THERAPY, HYPERGLYCEMIA, OR HYPOGLYCEMIA. THE HCP WAS MISSING PATIENT DATA FOR ONE PATIENT FROM (B(6) 2021 ONWARD AND COULD NOT TRACK PATIENT COMPLIANCE. IN THIS SITUATION, THE HCP COULD INCORRECTLY UPDATE THE PATIENT CARE PLAN BASED ON MISSING DATA. IN THIS SPECIFIC SITUATION, THERE WAS NO PATIENT HARM AS THE HCP/CLINICAL TRIAL STAFF RECOGNIZED THAT THE DATA WAS MISSING AND CONTACTED THE PATIENT AND SUPPORT TEAM. THE OTHER PATIENTS ENROLLED WERE NOT BEING IMPACTED BY THIS ISSUE. IT APPEARED ISOLATED TO JUST ONE USER. CURRENT RISK MITIGATIONS HELPED PREVENT A S3 IN THIS SCENARIO, SPECIFICALLY, THE CLINICAL STAFF NOTED THE MISSING BG READINGS WERE LISTED AS UNKNOWN AND THAT LED THEM TO REACH OUT TO THE PATIENT. THE PATIENT COULD STILL USE THE APPLICATION AND RECEIVE THE NECESSARY NOTIFICATIONS, WARNINGS, AND DOSE RECOMMENDATIONS. THE DOSE WAS BEING ADJUSTED AS EXPECTED BASED ON THE PATIENTS CARE PLAN. THE DATA WAS AVAILABLE ON THE PATIENT APPLICATION, BUT THERE IS A RISK OF LOST DATA AS THE DATA WAS NOT BEING TRANSFERRED TO THE BACKEND FOR THE USER. ON 09-APR-2021 (REPORTED AS THIS MORNING), DATA FOR THIS PATIENT ONLY, WAS NOT LOADING INTO THE PORTAL AS OF FRIDAY, APRIL 9TH. HCP (HEALTHCARE PROFESSIONAL) CALLED AND CONFIRMED WITH THE PATIENT THE APP SEEMS TO BE WORKING ON THEIR END AND THEY WERE UP TO DATE ON ENTERING BG AND INSULIN. ON 04-APR-2021, THE PATIENT ACCIDENTALLY ENTERED THEIR BG AS AN INSULIN DOSE. EVENT ASSESSED AS INTERVENTION REQUIRED. NO RELEVANT LABORATORY DATA WAS REPORTED. THE ACTION TAKEN WITH THE SUSPECT DEVICE WAS NOT APPLICABLE. IT WAS UNKNOWN, IF THE PATIENT RECEIVED ANY CORRECTIVE TREATMENT. THE OUTCOME OF THE EVENT WAS UNKNOWN. SAMPLE STATUS - NOT AVAILABLE INVESTIGATION REVEALED: 2021-05-04 VOLHA SAUCHANKA (ANALYST NAME ABBREVIATION) ADDED INVESTIGATION DETAIL FROM MEDTECH_US, PTC NUMBER-100118387, DEFECT MANAGEMENT TOOL-ESR-462 INVESTIGATION DETAILS: US (UPMC) COMPLAINT ORIGIN - CALL CENTER ENVIRONMENT-PRODUCTION VERSION AFFECTED-V2.3 FREQUENCY OF OCCURRENCE-SEEN ONCE CONCLUSION: TWO WEEKS AFTER SANOFI WAS NOTIFIED ON THE ISSUE, THE UPMC STUDY COORDINATOR INFORMED SANOFI THAT ALL OF THE PATIENT INFORMATION WAS NOW VISIBLE IN THE PORTAL. COMPLETELY UP TO DATE. NO ROOT CAUSE HAD BEEN IDENTIFIED FOR THIS ISSUE SO FAR AND THUS THE CASE WOULD BE MOVED TO THE BACKLOG FOR FURTHER MONITORING. FINAL INVESTIGATION COMPLETE DATE: 04-MAY-2021 SUMMARIZED CONCLUSION FOR THIS CASE WAS; RELATED TO PRODUCT. CORRESPONDING FIELDS AND NARRATIVE WAS UPDATED ACCORDINGLY. ADDITIONAL INFORMATION REGARDING A PRODUCT TECHNICAL COMPLAINT (PTC) WAS INITIATED ON 12-APR-2021 FOR MY DOSE COACH. BATCH NUMBER AND EXPIRATION DATE WERE UNKNOWN. GLOBAL PTC NUMBER: 100118387, WAS RECEIVED ON 21-JUN-2021: SAMPLE STATUS- NOT AVAILABLE INVESTIGATION REVEALED: 2021-06-21 VOLHA SAUCHANKA (ANALYST NAME): ESR-462 COMET CASE NUMBER: 100118387 COUNTRY OF ORIGIN: US (UPMC STUDY) COMPLAINT DESCRIPTION: ESR-462: EMAIL RECEIVED BY UPMC STUDY COORDINATOR ON 12 APRIL 2021: HI, ANOTHER PARTICIPANTS DATA IS NO LONGER DISPLAYING IN THE PORTAL. THE DATA STOPPED SHOWING IN THE PORTAL AS OF FRIDAY, APRIL 09TH. INVESTIGATION RESULTS: ANALYSIS OF THE REPORTED INFORMATION AND DE-IDENTIFIED DATA SHOWS THAT THE IOS APP INTERMITTENTLY STOPS SENDING THE DATA TO THE BACKEND SERVICES WHEN IT FAILS TO RENEW THE EXCHANGE TOKEN. A SECURED TOKEN IS USED BY THE IOS APP TO SEND OBSERVATION DATA (DOSE, AD-HOC BG, FBG ETC.) TO THE BACKEND WHICH IS USED BY THE PORTAL. AN EXPIRED TOKEN CAUSES THE APP TO NOT SYNC THE DATA WITH THE BACKEND, FURTHERMORE THE APP ALSO STOPPED ANY FUTURE ATTEMPTS TO SYNC THE DATA WHEN TOKEN EXPIRED THIS ERROR WOULD BE CORRECTED WHENEVER THE APP WAS RESTARTED. THIS RESULTED IN INTERMITTENT BEHAVIOR WHERE DATA DID NOT SYNC AND THEN SUDDENLY SHOWED UP ON THE PORTAL. THIS HAPPENED FOR A USER WHEN THE TRIAL COORDINATOR WORKED WITH THE PATIENT TO TROUBLESHOOTING THIS ISSUE RESULTING IN THE APP BEING RESTARTED. THE FIX FOR THIS ISSUE WILL BE IMPLEMENTED AS PART OF AN UPDATE RELEASE. RISK ASSESSMENT NO PATIENTS HAVE EXPERIENCED AN ADVERSE EFFECT FROM THIS ISSUE. THE HEALTHCARE PROFESSIONAL (HCP) IS MISSING PATIENT DATA AND CANNOT TRACK PATIENT COMPLIANCE WHICH IS AN S1 LEVEL RISK DUE TO POTENTIAL DELAY OF THERAPY. HOWEVER, IN LINE WITH THE RISK FILE AND HIGHEST MEDICAL RISK, THIS ISSUE COULD RESULT IN A DELAY OF THERAPY (S1), HYPERGLYCEMIA (S2), OR HYPOGLYCEMIA (S3) IF CURRENT RISK CONTROLS WERE NOT EFFECTIVE. THE HCP COULD POTENTIALLY INCORRECTLY UPDATE THE PATIENT CARE PLAN BASED ON MISSING DATA. IN THIS SPECIFIC SITUATION, THERE WAS NO PATIENT HARM AS THE HCP/CLINICAL TRIAL STAFF RECOGNIZED THAT THE DATA WAS MISSING. THE UPMC TEAM HAS BEEN MONITORING PATIENT DATA AND CURRENT RISK MITIGATIONS HELPED PREVENT AN S2 OR S3 IN THIS SCENARIO. THE PATIENT CAN STILL USE THE APPLICATION AND RECEIVE THE NECESSARY NOTIFICATIONS, WARNINGS, AND DOSE RECOMMENDATIONS. THE DOSE IS BEING ADJUSTED AS EXPECTED BASED ON THE PATIENT'S CARE PLAN. THE DATA IS AVAILABLE ON THE PATIENT APPLICATION, BUT THE PATIENT DATA IS NOT BEING TRANSFERRED TO THE HCP PORTAL FOR AN UNKNOWN TIME PERIOD. MDC V2.4 WAS ONLY BEING USED FOR THE UPMC CLINICAL TRIAL WITH CLINICAL ADMIN OVERSIGHT WHICH HAS BEEN PAUSED. CONCLUSION THE ROOT CAUSE HAS BEEN IDENTIFIED AND THE ISSUE WAS CAUSED BY THE EXPIRATION OF A SECURED TOKEN USED BY THE APP TO COMMUNICATE WITH THE BACK END. NO PATIENTS HAVE EXPERIENCED AN ADVERSE EFFECT FROM THIS ISSUE. ADDITIONALLY, THERE WAS NO PATIENT HARM. SANOFI HAS INSTRUCTED THE UPMC STUDY COORDINATOR TO PAUSE THE STUDY UNTIL THE FIX HAS BEEN IMPLEMENTED FOR THIS ISSUE IN AN UPDATE RELEASE. FINAL INVESTIGATION COMPLETE DATE: 21-JUN-2021 SUMMARIZED CONCLUSION: RELATED TO PRODUCT. CORRESPONDING FIELDS AND NARRATIVE WERE UPDATED ACCORDINGLY.
NO ADVERSE EVENT [NO ADVERSE EVENT] DEVICE MALFUNCTION [DEVICE MALFUNCTION] CASE NARRATIVE: INITIAL INFORMATION ALONG WITH A PRODUCT TECHNICAL COMPLAINT (PTC) RECEIVED ON 12-APR-2021 REGARDING AN UNSOLICITED VALID NON-SERIOUS MALFUNCTION CASE FROM AN OTHER HEALTH PROFESSIONAL IN UNITED STATES, INITIATED FOR MY DOSE COACH. BATCH NUMBER AND EXPIRATION DATE WERE UNKNOWN. GLOBAL PTC NUMBER: (B)(4). THIS CASE INVOLVES A PATIENT OF UNKNOWN DEMOGRAPHICS REPORTED SINCE THE HEALTHCARE PROFESSIONAL (HCP) COULD NOT SEE THE DATA THAT CAME FROM PATIENT APPLICATION (DEVICE MALFUNCTION), WHILE USING THE MEDICAL DEVICE MY DOSE COACH. MY DOSE COACH HAS BEEN IDENTIFIED WITH A PRODUCT USE ISSUE. IT IS UNKNOWN IF THE PRODUCT WAS STORED OR USED PROPERLY. THE DEVICE WAS OPERATED BY OTHER. THE PATIENT'S MEDICAL HISTORY, PAST MEDICAL TREATMENT(S), VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. CONCOMITANT MEDICATION WAS NOT REPORTED. ON (B)(6) 2021 (UNKNOWN LATENCY), AFTER THE INITIATION OF THE SUSPECT DEVICE, LOOKING AT THE PATIENT DATA FILE IT SEEMS THAT THE APP WAS NOT SYNCING OBSERVATIONS WITH THE SERVER. THERE ARE OTHER REQUESTS COMING IN FROM THE APP WHICH WERE BEING SUCCESSFULLY RESPONDED TO BY THE SERVER. THIS WAS AN INDICATION THAT THE APP TO SERVER COMMUNICATION WORKS FINE. THE LAST SUCCESSFUL REQUEST TO SYNC AN OBSERVATION WAS MADE ON (B)(6). APP HAD NOT MADE A SYNC REQUEST SINCE THAT DATE. THE HCP WAS STILL ABLE TO UPDATE OR CHANGE THE PLAN FOR THE PATIENT (IF REQUIRED) AND THE DOSE RECOMMENDATIONS AND REMINDERS (WHICH DID NOT REQUIRE ANY COMMUNICATION WITH THE SERVER) WERE STILL WORKING AS EXPECTED FOR THE PATIENT. THERE IS NO NOTIFICATION TO THE HCP OR PATIENT THAT THE APP WAS NOT SYNCING OBSERVATION DATA. FURTHER INVESTIGATION SHOWS THAT THE SERVER WAS RECEIVING OBSERVATIONS FROM OTHER PATIENTS, SO THIS PROBLEM EXISTS ONLY WITH PATIENT (B)(6). TO REPRODUCE THE ISSUE, A CARE PLAN WAS CREATED ON THE TEST ENVIRONMENT WITH ALL THE SAME PARAMETERS OF THIS PATIENT. IT WAS SENT TO AN IOS TEST BUILD TO INVESTIGATE FURTHER. THE TEST FAILED TO RECREATE THE SCENARIO. ALL OBSERVATIONS LOGGED DURING THE TEST WERE SYNCED WITH THE SERVER AND WERE VISIBLE IN THE PORTAL. ROOT CAUSE - MULTIPLE CAUSES WERE HYPOTHESIZED AND TESTED TO SEE IF THEY WOULD REPRODUCE THE ISSUE. 1. SECURE STORAGE KEY CHAIN. THE APP WAS WITH THE WRONG STORAGE KEY CHAIN. THIS SHOWS A MESSAGE ON THE HOME SCREEN SAYING THAT THE PLAN HAD BE DEACTIVATED (THE DEFAULT ASSUMPTION IF THE APP COULD NT CONFIRM THE USER OR PLAN ONLINE). RESTARTING WITH THE CORRECT KEY CHAIN RETURNED THE APP TO NORMAL. 2. BAD REQUEST. IF THE OBSERVATION REQUEST WAS NEVER SENT, IT WAS POSSIBLE THE REQUEST ITSELF FAILED TO BE CONSTRUCTED. THE APP WAS ALTERED TO PURPOSEFULLY FAIL TO CREATED THE ENDPOINT URL. THE APP WOULD JUST CRASH CONTINUOUSLY IN THAT CASE AS OBSERVATIONS WERE ATTEMPTED TO BE SENT. 3. CORRUPT DATABASE. IF THERE WERE SOME ISSUE ACCESSING THE DATA CONTEXT FOR EACH OBSERVATION IN THE DATABASE, THEIR FLAG FOR SYNCING MIGHT RESET AND NEVER BE SENT TO THE SERVER. IF THIS WERE THE CASE, NO EVENTS OF ANY KIND COULD BE UPDATED AND ONLY MISSED EVENTS WOULD APPEAR IN THE LOGBOOK. THE ROOT CAUSE WAS NOT DISCOVERED. SOFTWARE DEFECT - FAILED REQUIREMENT. STATEMENT OF SAFETY THIS ISSUE COULD RESULT IN A DELAY OF THERAPY, HYPERGLYCEMIA, OR HYPOGLYCEMIA. THE HCP WAS MISSING PATIENT DATA FOR ONE PATIENT FROM (B)(6) 2021 ONWARD AND COULD NOT TRACK PATIENT COMPLIANCE. IN THIS SITUATION, THE HCP COULD INCORRECTLY UPDATE THE PATIENT CARE PLAN BASED ON MISSING DATA. IN THIS SPECIFIC SITUATION, THERE WAS NO PATIENT HARM AS THE HCP/CLINICAL TRIAL STAFF RECOGNIZED THAT THE DATA WAS MISSING AND CONTACTED THE PATIENT AND SUPPORT TEAM. THE OTHER PATIENTS ENROLLED WERE NOT BEING IMPACTED BY THIS ISSUE. IT APPEARED ISOLATED TO JUST ONE USER. CURRENT RISK MITIGATIONS HELPED PREVENT A S3 IN THIS SCENARIO, SPECIFICALLY, THE CLINICAL STAFF NOTED THE MISSING BG READINGS WERE LISTED AS UNKNOWN AND THAT LED THEM TO REACH OUT TO THE PATIENT. THE PATIENT COULD STILL USE THE APPLICATION AND RECEIVE THE NECESSARY NOTIFICATIONS, WARNINGS, AND DOSE RECOMMENDATIONS. THE DOSE WAS BEING ADJUSTED AS EXPECTED BASED ON THE PATIENTS CARE PLAN. THE DATA WAS AVAILABLE ON THE PATIENT APPLICATION, BUT THERE IS A RISK OF LOST DATA AS THE DATA WAS NOT BEING TRANSFERRED TO THE BACK END FOR THE USER. ON (B)(6) 2021 (REPORTED AS THIS MORNING), DATA FOR THIS PATIENT ONLY, WAS NOT LOADING INTO THE PORTAL AS OF FRIDAY, (B)(6). HCP (HEALTHCARE PROFESSIONAL) CALLED AND CONFIRMED WITH THE PATIENT THE APP SEEMS TO BE WORKING ON THEIR END AND THEY WERE UP TO DATE ON ENTERING BG AND INSULIN. ON (B)(6) 2021, THE PATIENT ACCIDENTALLY ENTERED THEIR BG AS AN INSULIN DOSE. EVENT ASSESSED AS INTERVENTION REQUIRED. NO RELEVANT LABORATORY DATA WAS REPORTED. THE ACTION TAKEN WITH THE SUSPECT DEVICE WAS NOT APPLICABLE. IT WAS UNKNOWN, IF THE PATIENT RECEIVED ANY CORRECTIVE TREATMENT. THE OUTCOME OF THE EVENT WAS NOT APPLICABLE. SAMPLE STATUS- NOT AVAILABLE INVESTIGATION REVEALED: 2021-05-04 (B)(6) (ANALYST NAME ABBREVIATION) ADDED INVESTIGATION DETAIL FROM MEDTECH_US, PTC NUMBER-(B)(4), DEFECT MANAGEMENT TOOL-ESR-462 INVESTIGATION DETAILS: US ((B)(6)) COMPLAINT ORIGIN - CALL CENTER ENVIRONMENT-PRODUCTION VERSION AFFECTED-V2.3 FREQUENCY OF OCCURRENCE-SEEN ONCE CONCLUSION: TWO WEEKS AFTER SANOFI WAS NOTIFIED ON THE ISSUE, THE (B)(6) STUDY COORDINATOR INFORMED SANOFI THAT ALL OF THE PATIENT INFORMATION WAS NOW VISIBLE IN THE PORTAL. COMPLETELY UP TO DATE. NO ROOT CAUSE HAD BEEN IDENTIFIED FOR THIS ISSUE SO FAR AND THUS THE CASE WOULD BE MOVED TO THE BACKLOG FOR FURTHER MONITORING. FINAL INVESTIGATION COMPLETE DATE: 04-MAY-2021. SUMMARIZED CONCLUSION FOR THIS CASE WAS; RELATED TO PRODUCT. CORRESPONDING FIELDS AND NARRATIVE WAS UPDATED ACCORDINGLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 675301 | MY DOSE COACH | SOFTWARE | NDC | SANOFI-AVENTIS DEUTSCHLAND GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |