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

Model Number	102096-67A
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2022
Type of Reportable Event	Malfunction
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 received an early sensor replacement alert resulting in early sensor removal.
Additional Manufacturer Narrative
The sensor's in vitro qc was inconclusive due to the damaged hydrogel when the rma was received in-house.However, the investigation confirmed the customer's complaint via sensor's in-vivo data review.The root cause of the failure was likely to be delamination of the photodiodes from the epoxy bonding in the sensor.The investigation shows that the system correctly disabled the sensor due to performance failure (low overall glucose signals leading to msp) and the system's self-test functions are working normally.The sensor retired outside of the replacement policy period, thus the rma was issued for return of the sensor only.The user was advised to confirm their blood glucose with a blood glucose meter until a new sensor is inserted.D4.Updated additional device information.D6a.Implanted date updated to on (b)(6) 2022.H3.Device evaluated by manufacturer? yes.H4.Device manufacturer date updated to 03 may 2021.H6.Type of investigation updated to 10.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 4307.

• Brand Name: EVERSENSE SENSOR
• 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: 15270406
• Report Number: 3009862700-2022-00134
• Device Sequence Number: 6763154
• Product Code: QHJ
• UDI-Device Identifier: 00817491022349
• UDI-Public: 817491022349
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P160048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/23/2022
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP08507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2022
• Supplement Date Received by Manufacturer: 07/30/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2021
• 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: 59 YR
• Patient Sex: Male