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

Model Number 102208-704

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.The investigation concludes that the calibration entry at 7:25 pm cet (148 mg/dl) was unlikely to be an accurate calibration.The calibration entry made the system adjust the sensor readings higher than what it was being displayed.Then at 8:26 pm cet, the sensor readings were stable when the independent fingerstick measurement was taken which was 50 mg/dl.Alternatively, this fingerstick measurement may have been inaccurate.The sensor readings were stable in between this time indicating no significant change in glucose value.While the system may have offset-inaccuracy, the signal change on the sensor still would be evident for such rapidly changing glucose values.Furthermore, the fingerstick/calibration measurement following the event had an ard of 6%, which indicates there was good agreement between the fingerstick measurement and the sensor reading.Again, the sensor glucose had not significantly changed according to the raw readings in between this time.In summary: the sensor readings, per the raw measurements were stable during the time period reviewed.This indicates no significant glucose change over this interval.The first calibration reading corrected the sensor glucose level according to this higher value.The second measurement indicating the inaccurate/low glucose level was not confirmed by a significant drop in raw measurement values.The third measurement (second calibration) indicated the system was back to normal performance - again with no change in the raw sensor readings to indicate a shift in glucose value.It is not clear which of the entered finger sticks are inaccurate and for what reason.Usually, the sensor readings would rise after a hypoglycemic condition is treated but, in this case, sensor readings were declining and the fingerstick measurement at 9:26 pm cet proved that the system was displaying glucose readings correctly by the end of the time period under review.In conclusion we could not confirm the complaint and could not confirm that this was an instance of sensor inaccuracy.

Event Description

On february 16, 2021, senseonics was made aware of an incident where patient experienced hypoglycemia event.Patient woke up on (b)(6) 2021 and felt unwell.Sensor glucose (sg) reading was around 125 mg/dl and blood glucose meter (bgm) showed 50 mg/dl.She did not receive any alerts since sg value did not go below the low glucose alert level.

• 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: 18976381
• MDR Text Key: 338551251
• Report Number: 3009862700-2024-00180
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2021
• Device Model Number: 102208-704
• Device Catalogue Number: FG-3400-04-001
• Device Lot Number: 120314
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2020
• 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