MAUDE Adverse Event Report: SENSEONICS INCORPORATED EVERSENSE SENSOR; CONTINUOUS GLUCOSE MONITOR

Model Number 102095-67A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Local Reaction (2035)

Event Date 06/20/2019

Event Type  Injury  

Manufacturer Narrative

The user reported she had an allergic reaction to the methylmethacrylate material on the sensor.The patient is allergic to methylmethacrylcate and methoxyphenol, has had skin testing prior to the insertion and was aware of these allergies.The user did not report if the inserting healthcare professional was made aware of the patient's allergy prior to the sensor insertion.The user had the sensor removed on (b)(6) 2019 due to the allergic reaction she was experiencing on her upper arm and reported that she is now doing fine.

Event Description

On (b)(6) 2019, senseonics was made aware of an instance where a patient developed an allergic reaction to the eversense sensor on her upper arm.The patient was not treated with antibiotics and subsequently opted to have the sensor removed.

• Brand Name: EVERSENSE SENSOR
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): SENSEONICS INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: angela bandy ; 20451 seneca meadows parkway; germantown, MD 20876-7005 ; 3014072878
• MDR Report Key: 8819899
• MDR Text Key: 152020059
• Report Number: 3009862700-2019-00041
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491022349
• UDI-Public: 00817491022349
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/24/2019

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: 01/17/2020
• Device Model Number: 102095-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP05751
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2019
• 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
• Patient Age: 34 YR