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

Model Number 101368-67A

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

Patient Problem Numbness (2415)

Event Date 10/16/2018

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The physician reported that the numbness in the patient's arm is irreversible.The healthcare facility successfully removed the sensor.However care was not provided to the patient regarding the numbness of his upper arm as it was determined to be irreversible numbness.The device was not defective.The sterilization record for this lot of sensor was reviewed and the sensor was sterilized as per specifications.There is no remedial action/corrective action/preventive action/field safety corrective action required in this case as the device is not defective.The patient requested to not receive additional follow-up contact from the manufacturer.

Event Description

Senseonics was recently made aware of an incident where the patient experienced numbness in his upper arm subsequently after the eversense sensor was removed by his healthcare professional.The eversense sensor was inserted and removed at the same healthcare facility.

• Brand Name: EVERSENSE SENSOR
• Type of Device: IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR
• 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: 18297381
• MDR Text Key: 330089102
• Report Number: 3009862700-2023-00375
• 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: 12/08/2023

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: 09/15/2019
• Device Model Number: 101368-67A
• Device Catalogue Number: FG-4400-XX-302
• Device Lot Number: WP03662
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2019
• Initial Date FDA Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/17/2018
• 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