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Device Problem Application Program Version or Upgrade Problem (2881)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/14/2021
Event Type  Injury  
Event Description
Data is no longer displaying in the portal [device malfunction]. No adverse event [no adverse event]. Case narrative: initial information along with a product technical complaint (ptc) received on 20-may-2021 regarding an unsolicited valid non-serious malfunction case from consumer (patient) in united states, initiated for my dose coach. Batch number and expiration date were unknown. Global ptc number: (b)(4). This case involves patient with unknown demographic details who reported data was no longer displaying in the portal (device malfunction) while using the medical device my dose coach. My dose coach had been identified with a product use issue. It was unknown if the product was stored or used properly. The device was operated by the patient. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On (b)(6) 2021, (unknown latency) after the initiation of the suspect device, another participants data was no longer displaying in the portal. (device malfunction). This event was assessed as intervention required. No relevant laboratory data was reported. Action taken with suspect device was not applicable. It was unknown, if the patient received any corrective treatment. At time of reporting, the outcome was not applicable for the event device malfunction. Sample status - not available investigation results: on (b)(6) 2021 vs (analyst name abbreviation) investigation conclusion: related to product. Looking at the patient data file it seems that both apps were not syncing observations with the server. There were 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 was working. The last successful request to sync an observation was made on (b)(6) 2021. App had not made a sync request since that date. Once activated, the patient could use the application and receive dose recommendation without further intervention by the hcp (healthcare professional) until the dose plan expires, as configured by the hcp. The dose recommendations were calculated locally on the mobile application and did not require daily intervention from the hcp. 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. For the affected patients the dose was adjusted based on their current active dose plan prescribed by their hcp. There was no notification to the hcp or patient that the app was not syncing observation data. Risk assessment: no patients had experienced an adverse effect from this issue. The hcp was missing patient data and could not track patient compliance which was 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 us (upmc study) team had been monitoring patient data and current risk mitigations helped prevent an s2 or s3 in this scenario. 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 patient's care plan. The data was available on the patient application, but the patient data was not being transferred to the hcp portal for an unknown time period. In the previous related case ptc number (b)(4), the data was transferred to the hcp portal at a later date and no data was lost. Mdc v2. 4 was currently only being used for the upmc clinical trial with clinical admin oversight. Conclusion: esr-494 was the same issue as esr-462 (ptc number (b)(4)) and no root cause had been identified thus far. Investigation was still ongoing. No patients had experienced an adverse effect from this issue. Additionally, there was no patient harm. Sanofi had instructed the upmc study coordinator to contact the affected patients in order to let them know about the temporary inability of the hcp to monitor patient's data and contact study care team in case patient had any questions. Final investigation complete date: 02-jun-2021. No further relevant information was reported.
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Type of DeviceSOFTWARE
Manufacturer (Section D)
270 albany street
cambridge 02139
Manufacturer (Section G)
270 albany street
cambridge 02139
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
bridgewater 08807
MDR Report Key11991998
MDR Text Key267658924
Report Number3010770778-2021-00008
Device Sequence Number1
Product Code NDC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/14/2021 Patient Sequence Number: 1