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U.S. Department of Health and Human Services

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

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SANOFI US SERVICES INC. MY DOSE COACH INSULIN DELIVERY Back to Search Results
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.
 
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Brand NameMY DOSE COACH
Type of DeviceINSULIN 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 Key12120793
MDR Text Key270179361
Report Number3010770778-2021-00009
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
Report Date 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2021
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: 07/06/2021 Patient Sequence Number: 1
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