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

Model Number 101967-950

Device Problem Imprecision (1307)

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

Event Date 03/21/2024

Event Type  malfunction  

Event Description

On march 25, 2024, senseonics was made aware of an incident where the patient complained of inaccurate sensor readings.Patient provided two examples.A) (b)(6) 2024 at 6:00 pm, the sensor glucose (sg) value was 240 mg/dl and blood glucose (bh) value was 600 mg/dl.B) (b)(6) 2024 at 08:15 am, the sensor glucose (sg) value was 278 mg/dl and blood glucose (bg) value was 399 mg/dl.A review of the system performance in data management system (dms) did not indicate any malfunction or an issue with the system, but symptoms consistent with incorrect calibrations were observed.But the patient wanted to send the sensor back for evaluation to check if there was any malfunction.Hence this report is being submitted.There was a serious adverse event related to this issue which was earlier reported (bfarm case: (b)(4)).

Manufacturer Narrative

The manufacturer is currently performing investigation and the results will be provided in the supplemental report.

• 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: 19169791
• MDR Text Key: 341623109
• Report Number: 3009862700-2024-00636
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/24/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09143
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/28/2022
• 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