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	01/05/2022
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 investigation analysis, the event that was reported on (b)(6) 2022 at 1:52 pm pst (pacific standard time, user's local time) was after insertion.At 4:52 pm est (eastern standard time), the system displayed a sensor reading of 92 mg/dl.The reported fingerstick measurement of 47 mg/dl was not entered in the system as a calibration entry.Per the reported event, there was temporary mismatch between the sensor readings and fingerstick measurements.The hypo alert was not asserted as the sensor readings did not cross the low glucose alert threshold.Further analysis of the sensor diagnostic data showed the sensor was settling after insertion and this caused some transient noise in the optical channel measurements which led to some differences between the sensor readings and fingerstick measurements during the early sensor wear.Once the sensor settled, the system displayed better agreement between the sensor readings and the fingerstick measurements.User didn't provide if he was symptomatic or if he solved the event by himself, but didn't require medical treatment or hospitalization.User was advised to let the hcp know of these kind of events.No further resolution was found necessary for this complaint.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 213.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: 13459665
• Report Number: 3009862700-2022-00023
• Device Sequence Number: 12311921
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2022

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: 05/17/2022
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 124098
• 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: 01/05/2022
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• 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: 43 YR
• Patient Sex: Male