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

Catalog Number FG-5900-01-001

Device Problem Imprecision (1307)

Patient Problems Hypoglycemia (1912); Concussion (2192)

Event Date 06/15/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, senseonics was made aware of an adverse event where user experienced hypoglycemia and had a concussion and passed out.User's brother called the ambulance and took him to the emergency room.User was given glucose through iv in the emergency room.

Manufacturer Narrative

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

Manufacturer Narrative

The user experienced a hypoglycemia event where the user passed out while on a tractor.The user's brother saw him and called the ambulance where he was taken to the er and received glucose through an iv.Once the user's glucose levels were back to normal, he was discharged the same day.The user's sensor was not linked to his transmitter at the time of the event; thus, the device was not in use.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 213.H6.Investigation conclusions updated to 4310.

• 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: 17330883
• MDR Text Key: 319281051
• Report Number: 3009862700-2023-00149
• Device Sequence Number: 1
• Product Code: QHJ
• 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: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/17/2023
• Device Catalogue Number: FG-5900-01-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male