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

Model Number 101967-750

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

Patient Problem Discomfort (2330)

Event Date 05/19/2022

Event Type  Injury  

Event Description

Senseonics was made aware of an incident where patient reported that the sensor could not be removed in the practice after the completion of it's intended life period.Two unsuccessful attempts were made at the practice, one on (b)(6) 2022 and another on (b)(6) 2022.The employee of the practice then took the patient to the hospital where the sensor was located with the help of an image viewing system and was removed.The patient was then prescribed an antibiotic for safety as there were 3 incisions made for removal and the arm had several bruises.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Senseonics was made aware of an incident where patient reported that the sensor could not be removed in the practice after the completion of it's intended life period.Two unsuccessful attempts were made at the practice, one on (b)(6) 2022 and another on (b)(6) 2022.The employee of the practice then took the patient to the hospital where the sensor was located with the help of an image viewing system and was removed.The patient was then prescribed an antibiotic for safety as there were 3 incisions made for removal and the arm had several bruises.

• 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: 19009388
• MDR Text Key: 338980745
• Report Number: 3009862700-2024-00348
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491023360
• UDI-Public: 817491023360
• 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: 03/31/2024

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: 03/22/2022
• Device Model Number: 101967-750
• Device Catalogue Number: FG-4400-50-302
• Device Lot Number: WP08444
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 03/31/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/06/2021
• 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): Hospitalization