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

Model Number	102208-600
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	10/19/2023
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 (b)(6) 2023, senseonics was made aware of an adverse event where the user reported "not remembering much" from 4 hours (11am to 3pm) of the date of event when he was sitting alone at work.The user mentioned that his glucose level is usually low before and around noon, though on the date of event he did not check his sg and bg measurements.The user took some glucose gel around 3pm and did not require further medical intervention.The user made his hcp aware of the event.
Additional Manufacturer Narrative
The user reported experiencing a low glucose event on october 19, 2023, around 11am-3pm.He could not confirm if he was unconscious, but described the event as being "out of it" for 4 hours.The user did not check his sensor glucose, nor did he check his blood glucose values during the event.In an associated complaint for sensor inaccuracy (complaintrec-43378), it was determined that the system was experiencing some instability and eventually the system triggered a sensor replacement alert on 19 october 2023, which was addressed as part of complaintrec-43489, (mfr report #3009862700-2023-01029).A return material authorization (rma) was issued to offer the user a sensor replacement.Investigation results on the returned sensor revealed a loss of chemical performance.The system correctly disabled the sensor when it detected the performance failure, and the system's self-test functions were working normally.The root cause of the performance failure was due to oxidation of the chemical component of the sensor.B4.Date of this report updated to 26 december 2023.G3.Date received by manufacturer updated to 01 december 2023.H3.Device evaulated by manufacturer? yes.H6.Investigation findings updated to 3231.H6.Investigation conclusions updated to 4307.

• 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: 18166967
• Report Number: 3009862700-2023-00211
• Device Sequence Number: 17803885
• Product Code: QHJ
• UDI-Device Identifier: 00817491022929
• UDI-Public: 817491022929
• 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): 12/26/2023

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: 08/15/2023
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5901-01-001
• Device Lot Number: 131252
• 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: 10/20/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 11/19/2023
• Supplement Report FDA Received Date: 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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: 39 YR
• Patient Sex: Male