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 26 november 2022, senseonics was made aware of an adverse event where user experienced false hypoglycemia due to inaccuracies in sensor readings.

Manufacturer Narrative

Based on the investigation analysis, the reported event was due to a temporary mismatch, which was probably due to the insertion site still healing at the time.The reported event was on the 4th day after insertion, when the sensor was likely to be still stabilizing after insertion.Once the sensor stabilized after insertion, the system began performing within expectations, and there was better accuracy between the sensor readings and fingerstick measurements.User didn't seek medical attention and didn't need to self resolve the event as the blood glucose (bg) was in normal range.User was explained about early sensor wear and was recommended to perform timely calibrations ( ref case: complaintrec-(b)(4) ).Per dms, user is currently using the system with up to date information.No further resolution was found necessary for this complaint.D4.Device information updated.H3.Device evaluated by manufacturer?: yes.H4.Device manufacture date updated to 6 january 2022.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: 16047882
• MDR Text Key: 306155573
• Report Number: 3009862700-2022-00196
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022929
• UDI-Public: 817491022929
• 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: 11/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/06/2023
• 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: 11/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2022
• 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: 47 YR
• Patient Sex: Male