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

Model Number 101967-950

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 06/25/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The initial investigation was performed on the user synced glucose data on data management system (dms), which is an eversense cloud platform.Based on the initial investigation analysis, the customer reported mismatch on (b)(6) 2023 at the time of event was confirmed.The sensor glucose (sg) reading was 8.5 mmol/l and there was a calibration entry of 3.4 mmol/l.This calibration entry was marked suspicious and the system prompted for an additional calibration 1 hour later.However, the user did not enter additional calibration but instead entered a manual glucose entry of 8.4 mmol/l at 7:13 pm which closely matched with the sg reading of 7.2 mmol/l, at that time.A manual glucose entry is just for a record and will not be used by system as calibration.Following this event, there were several mismatches which showed that the sensor performance was deviating from the normal behavior and this led to suspend alert per design[?]this feature allows the system to re-evaluate its performance and re-start in initialization phase, while the sensor glucose is blinded to the user for 6 hours.There were 2 sensor suspend alerts asserted on (b)(6) 2023 and (b)(6) 2023 respectively.As per design, if there are two sensor suspend alerts asserted within 14 days, then the system will retire the sensor and assert a sensor replacement alert.To further investigate the complaint and to determine the root cause, a return material authorization (rma) was issued for the return of sensor.Investigation of the returned sensor did not reveal any malfunction as it passed all the functional tests.This may occur in some instances where the failure mode that presents itself in the body cannot be reproduced in the lab.A further analysis of the in-vivo glucose date showed that the rate of change in the glucose values frequently exceed 5 mg/dl and this noise could have potentially caused the failure.One of the potential root cause of such noise could be infection at insertion site.

Event Description

Senseonics was made aware of an incident where the customer experienced a hypoglycemia event on (b)(6) 2023 at 05:32 pm.The customer reported that sensor glucose (sg) was 8,5 mmol/dl where as the measured blood glucose (bg) value was 3,4 mmol/dl.The customer complained of not receiving a low glucose alert when measured bg value was low.The customer self resolved the issue by drinking and eating something.

• Brand Name: EVERSENSE SENSOR
• 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: 18117363
• MDR Text Key: 327880880
• Report Number: 3009862700-2023-00276
• 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: 11/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/12/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09082
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other