MAUDE Adverse Event Report: SANOFI US SERVICES INC. MY DOSE COACH; SOFTWARE

Device Problem Application Program Problem (2880)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

No adverse event [no adverse event].Device malfunction [device malfunction].Case narrative: initial information received on 15-dec-2021 regarding an unsolicited valid serious malfunction case from united states was received from a other health professional.This case involves an unknown age and unknown gender patient who experienced no adverse event and device malfunction with the use of 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 patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using my dose coach (with an unknown batch number, expiry date and indication).Malfunction summary: there are two patients (b)(6) whose observations are not seen in the hcp portal logbook and graph since (b)(6) respectively.Only information seen on the hcp portal logbook page for these patients is with regards to the dose recommendations that the patient receives in their mobile app.The patient mobile app is working correctly for basal titration recommendations.Patients can see all the recorded observations in their app.Expected results: observations reported by patients in app should be all seen on the hcp portal for the patients.Actual results: when notes section in the recorded observations from patient app contains emojis, they are not seen on the hcp portal.Patient id: (b)(6), country of origin: us ((b)(6) study).Investigation results: to investigate, all observation data recorded to this date in the backend was extracted.Looking at the data received by the backend it appears that the app is not sending all the data to the backend thereby leading to gaps in the available data.The screen-shots from the app show patient is regularly entering data but the data displayed in the portal is incomplete because the portal only displays the data visible in the backend.After further investigation it appears that the very first dosing event that failed to sync contains an emojis symbol in notes.After adding an emojis symbol (unicode) in notes field of a new dose we were able to reproduce the issue.None of the events (except dose recommendations) beginning with the event with an emojis symbol were syncing to the back end.Further investigation revealed that the application is sending the data to the back end, but the requests are being rejected and the app receives error 500 in response.The root cause of the issue is the back end does not accept observations with emojis symbols (unicode) in request.The investigation is still on going to determine if there are any other root causes that may be impacting this issue.Risk assessment: no patients have experienced an adverse effect or harm from this issue.This issue is impacting two patients using the application on android phones as part of the (b)(6) clinical study.It was determined as part of the investigation that this issue is caused by the patients using emojis in their notes.The hcp is missing patient observations and cannot track patient compliance which is considered 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 observations.In this specific situation, there was no patient harm as the hcp/clinical trial staff recognized that the observations were missing and reached out to the patients to ask if they had been logging their events.The (b)(6) team has been monitoring patient observations and current risk mitigation's prevented an s2 or s3 in this scenario.The patients can still use the application and receive the necessary notifications, warnings, and dose recommendations.The dose is being adjusted as expected based on the patients care plan.The patients observations are not seen in the hcp portal logbook and graph since (b)(6) respectively.Only information seen on the hcp portal logbook page for these patients is with regards to the dose recommendations that the patient receives in their mobile app.The patient mobile app is working correctly for basal titration recommendations.Patients can see all the recorded observations in their app.Mdc v2.4 is currently only being used for the (b)(6) clinical trial with clinical admin oversight.Conclusion: based on an initial assessment of this no ae product technical complaint, this was identified as reportable malfunction.Communication was sent to the (b)(6) coordinator instructing them to inform patients to not use emojis (unicode) as parts of the notes field while recording the observations until the investigation is completed, and a resolution had been reached.(b)(6) coordinator are also aware of this issue and have informed there hcps.Action taken: not applicable.Outcome: unknown.A product technical complaint (ptc) was initiated on 15-dec-2021 for my dose coach; batch number; unknown; global ptc number: (b)(4).Sample status is not applicable.Investigation is in process.Based on information previously received, the classification was deleted and reportable malfunction was updated to yes.Based on information previously received, the seriousness of device malfunction was updated to intervention required.

Event Description

No adverse event [no adverse event].Device malfunction [device malfunction].Case narrative: initial information received on (b)(6) 2021 regarding an unsolicited valid serious malfunction case from united states was received from a other health professional.This case involves an unknown age and unknown gender patient who experienced no adverse event and device malfunction with the use of 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 the.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using my dose coach (with an unknown batch number, expiry date and indication).On an unknown date the patient had a device malfunction.There was no adverse event.Malfunction summary: there are two patients (b)(6) whose observations are not seen in the hcp portal logbook and graph since (b)(6) respectively.Only information seen on the hcp portal logbook page for these patients is with regards to the dose recommendations that the patient receives in their mobile app.The patient mobile app is working correctly for basal titration recommendations.Patients can see all the recorded observations in their app.Expected results: observations reported by patients in app should be all seen on the hcp portal for the patients.Actual results: when notes section in the recorded observations from patient app contains emojis, they are not seen on the hcp portal.Patient id: (b)(6) country of origin: us (upmc study) investigation results: to investigate, all observation data recorded to this date in the backend was extracted.Looking at the data received by the backend it appears that the app is not sending all the data to the backend thereby leading to gaps in the available data.The screenshots from the app show patient is regularly entering data but the data displayed in the portal is incomplete because the portal only displays the data visible in the backend.After further investigation it appears that the very first dosing event that failed to sync contains an emoji symbol in notes.After adding an emoji symbol (unicode) in notes field of a new dose we were able to reproduce the issue.None of the events (except dose recommendations) beginning with the event with an emoji symbol were syncing to the back end.Further investigation revealed that the application is sending the data to the back end, but the requests are being rejected and the app receives error 500 in response.The root cause of the issue is the back end does not accept observations with emoji symbols (unicode) in request.The investigation is still on going to determine if there are any other root causes that may be impacting this issue.Risk assessment: no patients have experienced an adverse effect or harm from this issue.This issue is impacting two patients using the application on android phones as part of the upmc clinical study.It was determined as part of the investigation that this issue is caused by the patients using emojis in their notes.The hcp is missing patient observations and cannot track patient compliance which is considered 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 observations.In this specific situation, there was no patient harm as the hcp/clinical trial staff recognized that the observations were missing and reached out to the patients to ask if they had been logging their events.The upmc team has been monitoring patient observations and current risk mitigations prevented an s2 or s3 in this scenario.The patients can still use the application and receive the necessary notifications, warnings, and dose recommendations.The dose is being adjusted as expected based on the patients care plan.The patient's observations are not seen in the hcp portal logbook and graph since (b)(6) respectively.Only information seen on the hcp portal logbook page for these patients is with regards to the dose recommendations that the patient receives in their mobile app.The patient mobile app is working correctly for basal titration recommendations.Patients can see all the recorded observations in their app.Mdc v2.4 is currently only being used for the upmc clinical trial with clinical admin oversight.Conclusion: based on an initial assessment of this no ae product technical complaint, this was identified as reportable malfunction.Communication was sent to the upmc coordinator instructing them to inform patients to not use emojis (unicode) as parts of the notes field while recording the observations until the investigation is completed, and a resolution had been reached.Upmc coordinator are also aware of this issue and have informed there hcps.Action taken: not applicable.Outcome: unknown.A product technical complaint (ptc) was initiated on (b)(6) 2021 for my dose coach; batch number; unknown; global ptc number: (b)(4) device not returned.Ptc stated: added investigation detail from medtech_us.Communication was sent to the upmc coordinator instructing them to inform patients to not use emoji's (unicode) as parts of the notes field while recording the observations until the investigation is completed, and a resolution had been reached.Upmc coordinator are also aware of this issue and have informed there hcps.Final investigation complete date: 21-jan-2022.Summarized conclusion for this case is; related to product.Based on information previously received, the classification was deleted and reportable malfunction was updated to yes.Based on information previously received, the seriousness of device malfunction was updated to intervention required.Additional information received on 13-jan-2022 from other health care professional: no significant information added based on information previously received, the final ptc investigation results were added.Text amended.

• Brand Name: MY DOSE COACH
• Type of Device: SOFTWARE
• Manufacturer (Section D): SANOFI US SERVICES INC.; 270 albany street; cambridge 02139
• Manufacturer (Section G): SANOFI US SERVICES INC.; 270 albany street; cambridge 02139
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 13259032
• MDR Text Key: 289057195
• Report Number: 3010770778-2022-00001
• Device Sequence Number: 1
• Product Code: NDC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention