|
No adverse event [no adverse event], malfunction [device malfunction].Case narrative: based on the additional information received on 01-apr-2021, this case was initially considered as non serious was upgraded as serious.Initial information along with a product technical complaint (ptc) received on 23-mar-2021 regarding an unsolicited valid non-serious malfunction case from a 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 is linked to case (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 app (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 patient.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, the portal part of the production system was updated from 2.3 to 2.4.The apps were supposed to be updated on 26-mar-2021.After (b)(6) 2021, healthcare professional could not see the data that came from patient app (device malfunction) on the hcp portal.Current understanding of the issue was that there was an incompatibility between the app and the portal.A schema change happened during 2.4 development that now prevented data logged on 2.3 app to be saved on the cloud for showing to the doctor in the portal.The 2.4 app fix of a software defect found during design verification included the addition of a flag "issetupdose" that was required and was not part of 2.3, resulting in a compatibility issue between the portal and application.An upgraded patient app 2.4 in the field would resolve the issue and the observations would sync correctly with the cloud.Root cause (+detailed): software defect - failed requirement.Affected requirements: yes.Inputs, outputs or tests affected: (b)(4).Impact: function did not work, workaround was not possible or feasible.Risk analysis ids: (b)(4).Statement of safety: in this specific situation there was no patient harm.The hcp/clinical trial staff recognized that the data was missing and contacted the l1 and med team.While the hcp portal was missing the observations, the patient could still see their data and use the application and receive the necessary notifications, warnings, and dose recommendations.The dose was being adjusted as expected based on the care plan.The data was available on the patient application.The defect was investigated, and it was recommended to the clinical staff to contact the patients as per the attached e-mail.If this event had gone undetected, this situation could result in a delay of therapy, and potentially, albeit unlikely, result in hyperglycemia or hypoglycemia should the hcp incorrectly update the patient care plan based on missing data.Note that v2.3 of mdc was only for limited commercial release and used for the (b)(6) clinical trial.Three patients were currently enrolled in the study.The hcps and patients will be notified of the issue and closely monitored until the issue was fully resolved.No additional patients will be enrolled in the study until the issue was resolved.On (b)(6) 2021 (reported as this morning), the hcp looked into the portal and noticed no data was showing up for the patients after (b)(6) 2021 (thursday) and no data for a patient after (b)(6) 2021 (wednesday).The patient was asked and was not having any issues with the app and had been entering data.The patient was able to see all of the entries up to that morning.The healthcare professional asked another patient as well and was waiting to hear back.This event was assessed as intervention required as per reporter.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: requested and awaited.Complaint status: in progress.No further information was received.A product technical complaint (ptc) was initiated for my dose coach.Batch number- 2_3_0 and expiry date: unknown, global ptc number: (b)(4).Sample status: not received.Investigation revealed: added investigation details component/s: (b)(6) affects version/s: v2.3 origin: call center udi/build: (b)(4).Investigation details: current situation at (b)(6): there are 3 patients enrolled and activated on mdc application.All patients can enter the data in the mobile app and see the data on their app.Hcp cannot see any data after (b)(6) for patient 1 on clinic portal.Hcp cannot see any data after (b)(6) for patient 2 on clinic portal.Similar issue for patient 3 as well.Conclusion: an incompatibility between portal 2.4 and apps 2.3 has led to an issue of hcp not being able to track patient compliance and reviewing patient data from (b)(6) 2021 onward.The hcp could incorrectly update the patient care plan based on missing data.While the hcp portal is missing the observations, the patient can still use the application and receive the necessary notifications, warnings, and dose recommendations.An upgraded patient app 2.4 in the field will resolve the issue and the observations will sync correctly with the cloud.The interim investigation report was shared with gpv who decided to submit this issue to the fda using 30d report.A fix has been published to the (b)(6) app store on march 26th, and the (b)(6) study coordinator is able to see patient data in the portal.An event has been created to document this quality issue in (b)(6).Final investigation complete date: 01-apr-2021.Summarized conclusion for this case is; related to product.The batch number of the suspect device was updated.Corresponding fields and narrative was updated accordingly.
|
