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

Model Number 102208-904

Device Problem Calibration Problem (2890)

Patient Problem Hypoglycemia (1912)

Event Date 02/15/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The investigation was performed on the user synced data on data management system (dms) which is a cloud platform for the glucose data.Based on the investigation analysis, the reported event on (b)(6) 2023 could not be confirmed as the customer mentioned to have not taken blood glucose (bg) measurement for comparison.The eversense system was displayed a sensor glucose reading of 50 mg/dl at the time of incident.The system had asserted low glucose alerts as the sensor glucose reading was below the low alert threshold of 60 mg/dl.Per the analysis, there was good agreement between the sensor readings and fingerstick (bg) measurements before and after the reported event.The overall sensor performance was within expectations.

Event Description

Senseonics was made aware of an incident where the user complained of receiving constant hypoglycemia warnings from the eversense cgm system at night.When the user eats something and thinks glucose would have stabilized, the sensor glucose (sg) readings remain stuck in the hypoglycemia range and continues to receive low glucose alerts.The user reported that on (b)(6) 2023 at around 3:15 am, the sg value was 50 mg/dl and bg value was not taken (for confirmation).The user ate something as a remedial measure and after sometime, the sg reading was showing 54 mg/dl but the measured bg value was 196 mg/dl.

• Brand Name: EVERSENSENSE 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: 18117057
• MDR Text Key: 327885582
• Report Number: 3009862700-2023-00251
• Device Sequence Number: 1
• Product Code: QHJ
• 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: 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: 08/30/2023
• Device Model Number: 102208-904
• Device Catalogue Number: FG-3500-04-001
• Device Lot Number: WP08962
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2022
• 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