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

Model Number 102208-005

Device Problem Insufficient Information (3190)

Patient Problem Hypoglycemia (1912)

Event Date 10/15/2019

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.Based on the investigation, the system did assert predictive low alerts and low glucose alerts between (b)(6) 2019.However, based on the case notes, as the exact date and time of the hypo event is not known, it cannot be determined if there was a malfunction of the system.Per the investigation conducted on the available information, the system functioned as designed.

Event Description

On october 18, 2019, senseonics became aware of an event where the patient was hospitalized in the emergency room due to hypoglycemia event due to sensor inaccuracy.The patient fainted and she remained under observation for three hours.

• 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: 18637024
• MDR Text Key: 334492261
• Report Number: 3009862700-2024-00118
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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
• Report Date: 02/02/2024

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 Expiration Date: 09/28/2019
• Device Model Number: 102208-005
• Device Catalogue Number: FG-3400-XX-001
• Device Lot Number: 109867
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 02/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2018
• 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