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

Model Number 101967-950

Device Problem Connection Problem (2900)

Patient Problem Hypoglycemia (1912)

Event Date 01/28/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The transmitter disconnection may generally happen when the bluetooth connection between the smart transmitter and mobile device is interrupted.In case of such transmitter disconnections, the alerts will not appear on the mobile device.The user said they were able to reconnect the transmitter manually, but the disconnection issues often occur.A further review of the issue revealed that user had received many "data unavailable" alert, a situation where system's internal checks detect a system error.The transmitter disconnection issue was likely caused due to data unavailable alert.It is mentioned in our user guide that whenever a user receives multiple "data unavailable" alert, they need to perform a transmitter reset.The user can do the reset on their own by referring to the troubleshooting section of the user guide.In this case, the issue was resolved through assistance from customer care.Once the reset of the transmitter was completed, the transmitter disconnection issue got resolved.This issue was resolved via troubleshooting process by customer care and did not require any further investigation.The user has not reported sensor inaccuracies or any other issue with the performance of the system.The hypoglycemia events were true events and the user took the remedial action through self treatment.The user did not require any medical attention.The user is currently using the eversense cgm system with up to date glucose information.

Event Description

Senseonics was made aware of multiple hypoglycemia events on (b)(6) 2023 where the eversense cgm system did not alert the user because of disconnection from the transmitter.The user reported the below examples.1) between 11:23 am and 11:28 am | sensor glucose (sg) between 63 mg/dl and 64 mg/dl - no blood glucose (bg) provided.2) between 12:23 pm and 12:28 pm | sg between 60 mg/dl and 61 mg/dl - no bg provided.3) between 1:38 pm and 1:48 pm | sg between 59 mg/dl and 60 mg/dl - no bg provided.User didn't seek for medical treatment and resolved the event by himself.User's hcp is aware of the event.

• 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: 18117217
• MDR Text Key: 327887524
• Report Number: 3009862700-2023-00247
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 11/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/29/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-3500-05-001
• Device Lot Number: WP09010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2022
• 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