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

Model Number 102208-600

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 02/04/2024

Event Type  Injury  

Manufacturer Narrative

The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Event Description

On (b)(6) 2024, senseonics was made aware of an incident where user reported of hypoglycemic event due to inaccuracies in sensor readings and the system did not alert the user.

Manufacturer Narrative

The user complained of a hypoglycemic event where the bg was at 49 mg/dl and the sg read 74 mg/dl on 4 feb 2024, 02:09 pm.A review of the glucose trend data on (b)(6) 2024 confirmed the event described in the complaint where bg = 49mg/dl at 2.09 pm and sg = 74/mg/dl at 2.02 pm.User did not receive a low glucose alert as the sg did not reach the low alert setting which is set to 65 mg/dl.Customer did not seek for medical treatment and resolved the event by eating.In associated sensor inaccuracies case, created to document sensor inaccuracies, it was determined that the system observed a period of transient optical instability contributing to occasional differences.Once the sensor recovered from instability, accuracy improved.The overall sensor performance was evaluated after the event, and the sensor is performing with expectations.The user is currently using the system with no further inaccuracy complaints.B4: date of this report 25 april 2024.G3: date received by the manufacturer? 22 march 2024.H3: device evaluated by manufacturer? yes.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 4315.

• Brand Name: EVERSENSE TRANSMITTER
• 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: 18841936
• MDR Text Key: 336957290
• Report Number: 3009862700-2024-00558
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022912
• UDI-Public: 817491022912
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 138354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female