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

Model Number 101967-950

Device Problem Material Separation (1562)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 11/29/2023

Event Type  Injury  

Manufacturer Narrative

The manufacturer is currently waiting for additional information regarding next sensor removal attempt.As per the information that was provided to senseonics, the sensor removal will take place in the month of (b)(6) 2024.The additional information will be provided in the supplemental report.

Event Description

Senseonics was made aware of an incident where the previous sensor could not be removed during removal procedure.The sensor was palpable, but very weak.The hcp used an ultrasound to locate the sensor, but it was too deep and had moved a little bit.The hcp decided to leave the wound to heal and schedule another removal procedure on a later date.

• 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: 18405876
• MDR Text Key: 331472980
• Report Number: 3009862700-2023-01020
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491023308
• UDI-Public: 817491023308
• 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: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/12/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09042
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/26/2022
• 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