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

Device Problem Use of Device Problem (1670)

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

Event Type  Injury  

Event Description

Device malfunction with no adverse event [device malfunction].Case narrative: based on information previously received on 27-may-2021, the following information had been amended as valid case and the reportable malfunction for device was updated from unknown to yes.Initial information received on 27-may-2021 (along with global ptc number: (b)(4) ) regarding an unsolicited valid serious case from a non-healthcare professional from united states.This case involves a patient of an unknown demographics for whom it was reported device malfunction, with the use of medical device my dose coach.The patient's medical history, past medical treatment(s), vaccination(s) and family history, concomitant medication were not provided.On an unknown date, the patient started using my dose coach (with an unknown strength, formulation, dose, route, frequency, batch number and expiry date) for an unknown indication.On an unknown date (latency: unknown), after the initiation of my dose coach, patient experienced device malfunction.Seriousness criteria: intervention required for the event device malfunction.No relevant lab data was reported.Action taken was not applicable with my dose coach.It was not reported if the patient received a corrective treatment.Event outcome was unknown for device malfunction.A product technical complaint (ptc) was initiated on 27-may-2021 for my dose coach; batch number: expiration date: unknown, with global ptc number: (b)(4) was received by sanofi on 02-jun-2021.Sample status: not available.Final investigation complete date: 02-jun-2021.Summarized conclusion: related to product.There will be no information on the batch number was requested.No further relevant information was requested.A product technical complaint (ptc) was initiated on 27-may-2021 for my dose coach; batch number: expiration date: unknown, with global ptc number: (b)(4) was received by sanofi on 21-jun-2021.Sample status: same as before.Final investigation complete date: 21-jun-2021.Summarized conclusion: same as before.Corresponding fields and narrative were updated accordingly.Based on information previously received, the following information (case was upgraded to serious, tick box intervention required for the event device malfunction, other reportable incidents need to be selected in eu/ (b)(6) device form, malfunction is required to be selected in the incident characterization field in the device information) have been amended.

• Brand Name: MY DOSE COACH
• Type of Device: INSULIN DELIVERY
• 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: 12120793
• MDR Text Key: 270179361
• Report Number: 3010770778-2021-00009
• 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
• Type of Report: Initial
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention