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

Model Number 102208-600

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 07/14/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2023, senseonics was made aware of an incident where the user reported experiencing a hypoglycemia event with no alert asserted by the system due to an inaccuracy in sensor reading.

Manufacturer Narrative

The user reported a low glucose event on (b)(6) 2023 at 4:00 am with sg=108 mg/dl and bg=37 mg/dl.Review of the glucose trend showed sg=108 mg/dl at 3:42 am, but there was no bg entry at the time, thus the customer complaint could not be confirmed.The user did not receive the low glucose alert due to the sg value not crossing the low alert threshold limit set at 65 mg/dl.In an associated complaint of sensor inaccuracy, it was determined that there was some variation in the sensor values due to the early wear period, where the sensor was still stabilizing after insertion and the user should see continued improvements over the next few days.Sensor readings showed improvement in matching calibrations during the two weeks preceding the reported event.The user is currently using the system.The user didn't seek medical treatment and resolved the event by eating some food.The current system performance is within expectations and per dms, the user is currently using the system with up-to-date information.No further resolution was found necessary for this complaint.B4.Date of this report updated to 3 november 2023.G3.Date received by manufacturer updated to 25 august 2023.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 213.H6.Investigation conclusions updated to 67.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20875-7005
• MDR Report Key: 17499523
• MDR Text Key: 320798333
• Report Number: 3009862700-2023-00162
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022912
• UDI-Public: 817491022912
• 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: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/22/2023
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 131431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2022
• 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: 51 YR
• Patient Sex: Prefer Not To Disclose