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

Model Number 102208-922

Device Problem Connection Problem (2900)

Patient Problem Hypoglycemia (1912)

Event Date 02/17/2023

Event Type  Injury  

Event Description

Senseonics was made aware of an incident where the user complained of not receiving a hypoglycemia alert from the eversense cgm system due to the sensor not being linked with the transmitter at the time of event, experiencing "no sensor detected" alert.According to the user, the hypoglycemia event happened on (b)(6) 2023, but no exact time of the event was provided.User claimed that the blood glucose (bg) reading at the time of incident was 49 mg/dl.The user did not require any medical attention.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The investigation analysis was performed on the user synced glucose data on data management system (dms), which is an eversense cloud platform.Based on the investigation analysis, it was observed that the customer received multiple "no sensor detected" alerts on (b)(6) 2023.The eversense cgm system triggers "no sensor detected" alert whenever the connection between sensor and transmitter is lost.The customer care assisted the customer to troubleshoot this issue, but the problem persisted.In order to further investigate the issue, the customer was requested to send the transmitter diagnostic data.Despite providing instructions to send the diagnostic data, the customer did not it.As a result, no further investigation was possible for this issue.The reported hypoglycemia event could not be confirmed in the dms as the customer did not provide the time of event and also the reported bg value of 49 mg/dl was not found.Most probably, the customer did not enter the value into the dms.As per the dms analysis, there were multiple hypoglycemia events on (b)(6) 2023 between 6:49 am and 9:49 am and the eversense system asserted predictive low glucose alerts during that time.The overall sensor performance was within expectations and no malfunction was observed.In conclusion, the root cause for "no sensor detected" alert could not be determined due to customer unwilling to provide diagnostic data.

• 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: 18117072
• MDR Text Key: 327885611
• Report Number: 3009862700-2023-00252
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: PL
• 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: 10/03/2023
• Device Model Number: 102208-922
• Device Catalogue Number: FG-3500-22-001
• Device Lot Number: WP08962
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2022
• 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