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

Model Number 102208-905

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 07/09/2023

Event Type  Injury  

Manufacturer Narrative

The investigation was performed on the user synced glucose data on data management system (dms), which is an eversense cloud platform.Based on the review of the glucose data, the sensor glucose (sg) value was 329 mg/dl at 6:06 pm, but there was no blood glucose (bg) entry.Customer reported that the bg value was 35 mg/dl after injecting the insulin of 5.37 units based on the sg value of 329 mg/dl.A review of the sensor raw data did not reveal any performance malfunction or any abnormalities.Overall, the bg and sg values fit well with some occasional differences due to lag, which is inherent to any cgm system, and due to calibration during the periods of rapid glucose changes.Therefore, it can be concluded that the sensor was performing within expectations.The most probable root cause of the reported incident can be due to the insulin dosage which could have lowered the bg value.No further investigation was found necessary for this complaint.

Event Description

Senseonics was made aware of a customer experiencing a hypoglycemia event on (b)(6) 2023 at 06:10 pm.The customer reported that the measured blood glucose (bg) value was 35 mg/dl where as the sensor glucose (sg) reading was 329 mg/dl.The customer experienced this event while driving, after having spent a day at the pool.Prior to the incident at 05:37 pm, the customer had administered insulin based on the sg value shown by the eversense system.The insulin dosage lowered the bg resulting in a hypoglycemia event.The customer did not receive a low glucose alert at the time of incident, but instead received a high glucose alert because the sg value was above the high alert threshold.The customer self resolved the incident by drinking a cola.The customer did not require any medical attention.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876-7005
• MDR Report Key: 18117235
• MDR Text Key: 327866347
• Report Number: 3009862700-2023-00280
• 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: 12/26/2023
• Device Model Number: 102208-905
• Device Catalogue Number: FG-3500-05-001
• Device Lot Number: 134547
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other