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

Model Number 101368-67A

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

Patient Problems Hemorrhage/Bleeding (1888); Discomfort (2330); Swelling/ Edema (4577)

Event Date 04/04/2019

Event Type  Injury  

Event Description

Senseonics was recently made aware of an incident where the patient reported that during her scheduled sensor removal procedure, the physician was having difficulty removing the sensor which resulted in a larger wound and excessive overnight bleeding and swelling at the removal site.The physician had not stitched the wound after sensor removal.The patient consulted her general practitioner physician who cleaned the wound, applied large steri strips and dressed the wound.There was no sign of infection and the wound is healing.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The sterilization record for this lot of sensor was reviewed and the sensor was sterilized as per specifications.The patient visited her general practice physician who cleaned and dressed the wound.This incident does not require any further investigation.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876-7005
• MDR Report Key: 18278420
• MDR Text Key: 329888088
• Report Number: 3009862700-2023-00369
• Device Sequence Number: 1
• Product Code: QCD
• 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: 12/06/2023

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: 11/30/2018
• Device Model Number: 101368-67A
• Device Catalogue Number: FG-4400-XX-302
• Device Lot Number: WP04048
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2019
• Initial Date FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/07/2018
• 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