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

Model Number 102208-904

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 07/25/2023

Event Type  Injury  

Event Description

Senseonics was made aware of an incident where the customer had a false hypoglycemia event on (b)(6) 2023 at 3 am.The customer reported that sensor glucose (sg) value that was shown by the eversense cgm system was incorrect.The sg value was 60 mg/dl at the time of incident.The customer did not measure any blood glucose (bg) value, but complained that the sg value was incorrect.The customer did not have to seek any medical attention or any remedial actions.

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 sensor glucose (sg) value on (b)(6) 2023 at 2:57 am was 57 mg/dl.No bg value was seen on dms at that time because the customer probably did not enter the value into the system.The initial investigation analysis revealed continuous gaps in glucose data and calibration past due alerts, suggesting that the transmitter was removed for long periods of time and the system was not used consistently.High levels of sensor variability were seen in brief times whenever the system was in use.To further investigate the sensor variability, a return material authorization (rma) was authorized for return of the sensor.However, the rma was never received.As a result, the no further investigation was possible and the root cause of the complaint could not be established.One potential root cause of the observed variability could be attributed to inconsistent system usage and not calibrating timely.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows pkwy; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows pkwy; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows pkwy; germantown, MD 20876-7005
• MDR Report Key: 18117264
• MDR Text Key: 327882496
• Report Number: 3009862700-2023-00288
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491023384
• UDI-Public: 817491023384
• 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: 08/05/2023
• Device Model Number: 102208-904
• Device Catalogue Number: FG-3500-04-001
• Device Lot Number: 131057
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/05/2022
• 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