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

Model Number	102096-67A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
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 07 june 2022, senseonics was made aware of an incident where user reports having to keep going back into initialization phase due to having two sensors in arm.
Additional Manufacturer Narrative
The user has two sensors in the same arm.If a sensor is inserted in the same arm and near an older sensor that was not removed, the transmitter may read information from the old sensor, interfering with system performance.User was advised to consult with the hcp to discuss the possibility of removing the old sensor, or removal of both sensors if unable to determine the location of the old sensor.Per notes of associated pm0 case, complaint: (b)(4), removal of the old sensor was not performed because it was unable to be palpated and no ultrasound guidance was available.Multiple follow ups were made to gather more information from the clinic, but was unresponsive.This incident does not require any further investigation.No resolution was possible due to lack of response from the clinic (ref case: complaint: (b)(4).H6.Investigation findings updated to 4247.H6.Investigation conclusions updated to 4316.

• 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: 14923882
• Report Number: 3009862700-2022-00103
• Device Sequence Number: 11270595
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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: 05/19/2022
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP08506
• 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: 06/07/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 52 YR
• Patient Sex: Male