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

Model Number 101967-730

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

Patient Problem Numbness (2415)

Event Date 06/20/2020

Event Type  Injury  

Event Description

Senseonics was made aware of an instance where the patient experienced feeling of electricity going through her arm and numbing of the fingers.There was no infection at the insertion site.Doctor decided to remove the sensor and patient's arm returned to normal almost immediately.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Follow up requests were made to the distributor regarding further information.However, no response was received.No further progress could be made on this complaint.Per the case notes, everything returned back to normal once the sensor was removed.Also, a review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.

• 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: 18571172
• MDR Text Key: 333606507
• Report Number: 3009862700-2024-00146
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: FI
• 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: 01/24/2024

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: 08/17/2020
• Device Model Number: 101967-730
• Device Catalogue Number: FG-4400-30-302
• Device Lot Number: WP07271
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/19/2019
• 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