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

Model Number 101967-950

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

Patient Problem Impaired Healing (2378)

Event Date 04/28/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.A review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.The insertion procedure involves making an incision, a subcutaneous pocket of 3mm - 5mm deep into skin and the sensor will be inserted in this pocket.This was the customer's 11th sensor (overall) and 5th sensor in that arm and such incidents had not happened previously.According to hcp, the insertion went "flawlessly" and even the customer felt it the incision looked good and inconspicuous.The sensor was inserted in a different pocket and are always changed/ repositioned.Also, there was no redness or swelling.Since the sensor slipped out of the arm, a courtesy sensor replacement was given to the user and the hcp will schedule another insertion appointment.The customer is doing fine and no medication was given by hcp.The sensor might have fallen out likely due to insertion wound not healing completely.In some patients, the incision or the insertion wound may take more time to heal and such delayed wound healing is a known and anticipated potential adverse effect.No further investigation was found necessary for this incident.

Event Description

Senseonics was made aware of an incident where the sensor slipped out of the customer's arm on (b)(6) 2023 at around 09:45 pm.This was the 11th sensor of the customer and it was inserted in the left upper arm on (b)(6) 2023.Each time the sensor was replaced, the arm was always stitched.There was no other sensor in the arm.The customer informed that the incision looked good and inconspicuous.There was no redness or swelling and the wound seemed to heal well as usual.The client still had the steri strips over the incision.He placed the patch with the transmitter over the steri strips.When customer removed the adhesive patch with the transmitter to charge the transmitter, the sensor slipped out of his arm.Hcp is aware of the event and no medication was prescribed.

• 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: 18117265
• MDR Text Key: 327888169
• Report Number: 3009862700-2023-00265
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/23/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP08965
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2022
• 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