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 Discomfort (2330)

Event Date 08/17/2023

Event Type  Injury  

Event Description

On february 3, 2024, senseonics was made aware of an adverse event where the user reported a failed removal attempt due to the sensor not being able to be found by the hcp during the removal and insertion procedure on (b)(6) 2023.A second removal attempt was made during the latest sensor insertion on (b)(6) 2024, but the hcp could not extract the sensor.

Manufacturer Narrative

According to the case notes, the user explained that during the second removal attempt, an ultrasound was used, and the sensor was located, but the hcp was still not able to extract the sensor.Several attempts were made to contact the hcp regarding the report, but no further investigation/troubleshooting could be possible for this complaint as the hcp never responded to the communications from customer care.No further information was available for this complaint.

• 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: 18794294
• MDR Text Key: 336396976
• Report Number: 3009862700-2024-00087
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/12/2023
• Device Model Number: 102096-81A
• Device Catalogue Number: FG-7200-00-301
• Device Lot Number: WP08882
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2022
• 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: 62 YR
• Patient Sex: Prefer Not To Disclose