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	04/15/2022
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 (b)(6) 2022, 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, the event was reported on the 2nd day after insertion on (b)(6), 2022.The sensor was settling after insertion and displayed temporary mismatch on (b)(6), 2022.Once the sensor settled, the system displayed better agreement between sensor readings and fingerstick measurements (please refer to the attached screenshots which captures the 2 weeks of glucose plot after insertion showing the mard is around 13.23%).Note: the hypo alert threshold was set at 90 mg/dl, so the hypo alerts were asserted more often, if the sensor readings were below 90 mg/dl.Per the analysis, the fingerstick measurements were not entered during the reported events as captured in the follow-up notes - a.(b)(6) 2022 7:03 pm ct | sg 84 mg/dl - no bg value entered.B.(b)(6) 2022 3:38 pm ct | sg 88 mg/dl - no bg value entered.C.(b)(6) 2022 1:41 pm ct | sg 76 mg/dl - no bg value entered.The overall sensor performance was within expectations and the system is displaying better accuracy (at the time of the analysis), where the mard is at 9.92% for the glucose plot between (b)(6), 2022 (refer to the attached screenshot).User wasn't symptomatic, didn't seek for medical treatment and resolved the event on her own.User was advised to let hcp know of these kind of events.User is currently using the system with up to date glucose information.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: 14305943
• Report Number: 3009862700-2022-00069
• Device Sequence Number: 4834048
• 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): 04/16/2022

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: 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: 04/16/2022
• Supplement Date Received by Manufacturer: 04/16/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2022
• 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
• Patient Age: 67 YR
• Patient Sex: Female