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	04/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, senseonics was made aware of an incident where user experienced hypoglycemia due to inaccuracies in sensor readings.
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Additional Manufacturer Narrative
Based on the analysis, the sensor readings captured in the case notes was confirmed at the following time of the day on (b)(6).Sensor reading - 120 mg/dl at 2:02 am est on (b)(6) 2022.Sensor reading - 133 mg/dl at 2:02 am est on (b)(6) 2022.Per the case notes, the reported fingerstick measurement of 60-62 mg/dl was not entered in the system and since the exact time of the event is not captured, the mismatch event could not be confirmed at this time.The sensor readings leading up to the reported event, displayed very good agreement between the sensor readings and fingerstick measurements (refer to the attached screenshot).Per the analysis, the system was performing within expectations at the time.User was symptomatic, but did not specify if he sought any medical attention or self resolved the event.User was advised to let hcp know of these events.Per the investigation analysis, the system was performing within expectations at the time.No further resolution was possible for this complaint as user was unresponsive to the communications from customer care.H3.Device evaluated by manufacturer? yes.

• 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: 14269713
• Report Number: 3009862700-2022-00068
• Device Sequence Number: 5908060
• Product Code: QHJ
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2022

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: 04/12/2022
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 123496
• 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: 04/08/2022
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2021
• 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: 61 YR
• Patient Sex: Male