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

Model Number 102812-67A

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 12/28/2021

Event Type  Injury  

Event Description

On (b)(6) 2022, senseonics was made aware of an incident where the user experienced low glucose symptoms and had to go to the emergency room.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

On (b)(4) 2022, senseonics was made aware of an incident where the user experienced low glucose symptoms and had to go to the emergency room.

Manufacturer Narrative

User could not provide any further details like glucose values, date and time of the incident.User was reached out multiple times to follow up regarding this incident and to get further details.However, no response was received from the user.Per data management system (dms), there is no use of system since (b)(6) 2022.Per case notes, user was admitted to er where user was given glucose water and some resting was enough.No further resolution was possible for this complaint due to lack of response from the user.H6.Investigation finding updated to 3221.H6.Investigation conclusions updated to 67.

• Brand Name: EVERSENSE SENSOR
• 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: 13586641
• MDR Text Key: 286042280
• Report Number: 3009862700-2022-00034
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491022523
• UDI-Public: 00817491022523
• 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: 02/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/15/2022
• Device Model Number: 102812-67A
• Device Catalogue Number: FG-4202-00-301
• Device Lot Number: WP08306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female