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

Model Number 102208-904

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 07/26/2023

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 glucose values could not be confirmed because the data between (b)(6) 2023 10:23 pm and (b)(6) 7:09 pm was not synced.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.

Event Description

Senseonics was made aware of an incident where the customer had a false hypoglycemia event on (b)(6) 2023 at 11 pm.The customer reported that sensor glucose (sg) went below the low alert threshold of 52 mg/dl triggering a low glucose alert.The sg value was 52 mg/dl where as the measured blood glucose (bg) value was 305 mg/dl.Since the measured bg value was very high, the customer injected insulin.The customer did not seek any medical treatment.

• 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: 18117259
• MDR Text Key: 327879904
• Report Number: 3009862700-2023-00287
• 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