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

Model Number 101967-950

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The patient could not link sensor with the transmitter as the sensor was never inserted.The sensor could not be palpated nor it was found during the ultrasound.The inserting physician (hcp) most likely forgot to check if the sensor got implanted or if it remained inside the insertion tool.The hcp will be re-trained on the procedure, as part of resolution.The patient was re-inserted with another sensor on (b)(6) 2023.Since this is procedure related adverse event, this does not require any further investigation.

Event Description

Senseonics was made aware of an incident where the patient reported that the sensor could link with the transmitter.The insertion procedure took place on (b)(6) 2023.The sensor could not be palpated.After an appointment with the hcp on (b)(6) 2023, it was confirmed that the sensor was not inserted as it could not be located in the hospital with ultrasound or with the transmitter.A new sensor was inserted during the appointment on (b)(6) 2023.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows pkwy; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows pkwy; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows pkwy; germantown, MD 20876-7005
• MDR Report Key: 18117345
• MDR Text Key: 327880226
• Report Number: 3009862700-2023-00299
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: SP
• 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: 11/12/2023

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: 02/16/2024
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09240
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/21/2023
• 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