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

Model Number 102208-610

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 11/26/2022

Event Type  Injury  

Manufacturer Narrative

The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Event Description

On 02 december 2022,senseonics was made aware of an incident where user experienced false hypoglycemia due to inaccuracies in sensor readings.

Manufacturer Narrative

Based on the investigation analysis, the reported event at 7:02 am est on november 26, 2022, could not be confirmed as there was no calibration entry of 92 mg/dl at 7:02 am est.However, per the analysis, there was a calibration entry at 6:50 am est (12 minutes prior to the reported event), which displayed good accuracy.The reported event happened during the initial few days after sensor insertion, and during this period of time, there could be chances of temporary mismatch due to the insertion site still healing at that time.This would eventually normalize as the sensor stabilizes.Once the sensor recovered after insertion, the system began performing within expectations and there was better accuracy between the sensor readings and fingerstick measurements.H3.Device evaluated by manufacturer?yes.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 4315.

• Brand Name: EVERSENSE 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: 16079936
• MDR Text Key: 306452867
• Report Number: 3009862700-2022-00201
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2023
• Device Model Number: 102208-610
• Device Catalogue Number: FG-5901-01-001
• Device Lot Number: 129895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• 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 Age: 52 YR
• Patient Sex: Female