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

Model Number 101967-950

Device Problems Installation-Related Problem (2965); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that the sensor got stuck inside the insertion tool, but later during another insertion procedure, sensor was inserted successfully.The hcp will be trained and educated again on the insertion procedure as part of resolution.No further investigation is possible for this complaint.

Event Description

On december 8, 2023, senseonics was made aware of an incident where the patient had to go through another insertion procedure because during the initial insertion procedure, the sensor got stuck in the insertion tool and was not inserted.The initial insertion procedure happened on (b)(6) 2023 and initially it was thought that sensor was inserted.But when the sensor was unable to be detected through the transmitter, it was determined that the sensor got stuck in the insertion tool itself.The patient went through another insertion procedure on (b)(6) 2023 and was inserted successfully.No clinical symptoms were reported by the user.

• 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: 18460454
• MDR Text Key: 332253467
• Report Number: 3009862700-2023-01030
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/23/2024
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09243
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/06/2023
• 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