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

Model Number 102208-906

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 08/10/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The user complained of discrepant measurements between capillary and sensor where the bg was at 48 mg/dl and the sg read 129 mg/dl on (b)(6) 2023, 11:16 pm.A review of the glucose trend data on (b)(6) 2023 confirmed the event described in the complaint, where the sensor recorded a glucose concentration of 129 mg/dl while the user measured a bg of 48 mg/dl at (b)(6) 2023, 11:16 pm.This calibration was marked as a suspicious fingerstick.In associated s4 case #(b)(4), created to document sensor inaccuracies, it was determined that the system observed a temporary period of variability, most likely due to early wear adjustment.It was also observed that some calibrations were entered after gaps in data, and it was recommended that the user may experience less lag by allowing the system to display 1-2 sg readings after a gap before entering a calibration.The overall sensor performance was evaluated after the event, and the sensor is performing with expectations.The user is currently using the system with no further inaccuracy complaints.

Event Description

Senseonics was made aware of an incident where the customer had a hypoglycemia event on (b)(6) 2023 at 11:16 pm.The measured blood glucose (bg) value was 48 mg/dl where the sensor glucose (sg) reading was 129 mg/dl.The eversense cgm system did not assert any alerts since the sg value was within normal glucose range.The customer did not require any medical attention and was able to self resolve.No further information was provided by the customer.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876-7005
• MDR Report Key: 18117356
• MDR Text Key: 327880220
• Report Number: 3009862700-2023-00292
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491023445
• UDI-Public: 817491023445
• Combination Product (y/n): Y
• Reporter Country Code: SP
• 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: 08/31/2023
• Device Model Number: 102208-906
• Device Catalogue Number: FG-3500-06-001
• Device Lot Number: 132066
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other