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

Model Number 102096-81A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 09/20/2022

Event Type  Injury  

Manufacturer Narrative

Development of infection at the sensor insertion site is a known and anticipated potential adverse effect.User reported an allergy because of white adhesive patches that caused the infection in the insertion site.User also mentioned that due to the allergic reaction, blood and pus came from the open incision.User doesn't have any other infection and was treated with antibiotic cream for the insertion site prescribed by health care professional and the incision is fully healed around five days after the appointment.A review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.No further investigation is required.

Event Description

On (b)(6) 2022,senseonics was made aware of an adverse event where user reported an allergy because of white adhesive patches that caused the infection in the insertion site.User also mentione that due to the allergic reaction, blood and pus came from the open incision.User doesn't have any other infection and was treated with antibiotic cream for the insertion site prescribed by health care professional and the incision is fully healed around five days after the appointment.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 15831248
• MDR Text Key: 303993131
• Report Number: 3009862700-2022-00176
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022950
• UDI-Public: 817491022950
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2023
• Device Model Number: 102096-81A
• Device Catalogue Number: FG-7200-00-301
• Device Lot Number: WP08819
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2022
• Initial Date FDA Received: 11/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Female