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

Model Number 102620-81A

Device Problem Difficult to Remove (1528)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 01/23/2024

Event Type  Injury  

Event Description

On (b)(6) 2024, senseonics was mad aware of an adverse event where the user experienced a failed removal attempt that left her arm feeling sore.

Manufacturer Narrative

Based on the case notes, the user experienced a failed removal attempt that lasted over 30 minutes.The user complained of pain during the procedure and was given lidocaine during the procedure.Although the sensor was palpable, it was not able to be seen during the ultrasound.There was another unsuccessful removal attempt on 16 february 2024.The sensor was located but the physician could not remove the sensor.The next removal attempt procedure will be scheduled for a later date.No further investigation is required.

• 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: 18754745
• MDR Text Key: 335932225
• Report Number: 3009862700-2024-00072
• Device Sequence Number: 1
• Product Code: QHJ
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/04/2023
• Device Model Number: 102620-81A
• Device Catalogue Number: FG-7201-00-301
• Device Lot Number: WP09023
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/06/2022
• 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: 45 YR
• Patient Sex: Female