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 01/14/2023

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 user experienced false hypoglycemic alerts due to inaccuracies in sensor readings.

Manufacturer Narrative

Based on the investigation analysis, the reported event or mismatch at 8:44 am est on january 14, 2023 could not be confirmed as there was no corresponding calibration entry at the time.However, around the time of the event, the system displayed temporary mismatch between the sensor readings and fingerstick measurements.The reported event happened during the initial few days after sensor insertion, and during the initial settling period after sensor insertion, there could be chances of temporary mismatch, which would eventually normalize as the sensor stabilizes.Once the sensor stabilized 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: 16396113
• MDR Text Key: 309749783
• Report Number: 3009862700-2023-00045
• 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: 01/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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
• Initial Date Manufacturer Received: 01/14/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 01/14/2023
• Supplement Dates FDA Received: 04/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2022
• 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 Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Male