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

Model Number 102208-500

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 02/26/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, senseonics was made aware of an incident where user experienced false hyperglycemia due to inaccuracies in sensor readings.

Manufacturer Narrative

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

Manufacturer Narrative

The complaint was investigated, and though the reported sg and bg values did not match with that in the data management system (dms) except for one bg value, mismatches between the bg and sg values in the early days of the sensor might be due to the initial variability of the system, as the calibrations were still helping the system adjust.Per the case notes of associated sensor inaccuracies complaint (sf #00076383), there is a better agreement between sg and bg values and user is using the system with up to date information.No further investigation was found necessary for this complaint.User wasn't symptomatic, didn't seek medical treatment and didn't need to self treat as no symptoms were shown.As user's hcp was not aware of the event, user was advised to let hcp know.Per dms, user is currently using the system with up to date information.D2.Product code updated to qhj.H3.Device evaluated by manufacturer? yes.H6.Investigation findings changed to 114.H6.Investigation conclusion changed 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 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: 13932552
• MDR Text Key: 288087295
• Report Number: 3009862700-2022-00048
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491021441
• UDI-Public: 00817491021441
• 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: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/05/2022
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 123461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2021
• 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: 59 YR
• Patient Sex: Male