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

Model Number	102208-620
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Event or Problem Description
On may 16, 2023, senseonics was made aware of an adverse event where the user received a false hypoglycemia alert due to a sensor inaccuracy.
Additional Manufacturer Narrative
Based on the investigation analysis, the reported event at 9:24 am est on (b)(6) 2023, could not be confirmed as there was no corresponding calibration entry at the time.However, the calibration entry of 49 mg/dl at 9:17 am est on (b)(6) 2023, displayed better agreement with the sensor reading of 40 mg/dl at the time.The reported event happened during the early sensor wear after sensor insertion, and during the initial settling period after sensor insertion, there could be chances of temporary mismatch, which would eventually normalize as the sensor stabilizes.Once the sensor recovered after insertion, the system began performing within expectations and there was better accuracy between the sensor readings and fingerstick measurements.H3.Device evaluated by manufacturer?yes.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 4315.

• 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: 17131280
• Report Number: 3009862700-2023-00134
• Device Sequence Number: 15083815
• Product Code: QHJ
• UDI-Device Identifier: 00817491022936
• UDI-Public: 817491022936
• 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): 05/16/2023

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: 05/09/2023
• Device Model Number: 102208-620
• Device Catalogue Number: FG-5902-01-001
• Device Lot Number: 129740
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Male