MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE TRANSMITTER; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

Model Number	102208-500
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is result of a retrospective review of complaints.The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Event or Problem Description
On (b)(6) 2021,senseonics was made aware of an incident where user experienced hypoglycemia due to inaccuracies in sensor readings.
Additional Manufacturer Narrative
Based on the investigation analysis, it was confirmed the system asserted the hypo alerts from 4:10 pm est until 6:45 pm est on (b)(6) 2021.Per (b)(4), several attempts were made to contact the user to troubleshoot the issue where the user reported not hearing the alerts on the mobile device.Since the user was unresponsive to communication attempts, follow-up response is not available at the time to conclude if there was any issue with the mobile device or the transmitter.There could be no further investigation performed at this time.Per case notes, user mentioned that he has experience and knows how to treat the hypoglycemia episodes.No further resolution details are available for this complaint.H6.Investigation findings updated to 3221.H6.Investigation conclusions updated to 67.

• Brand Name: EVERSENSE TRANSMITTER
• Common Device Name: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20875-7005
• MDR Report Key: 13287508
• Report Number: 3009862700-2022-00013
• Device Sequence Number: 4728090
• Product Code: QCD
• UDI-Device Identifier: 00817491021441
• UDI-Public: 00817491021441
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P160048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/19/2022
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 122946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Male