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

Model Number 102208-005

Device Problem Imprecision (1307)

Patient Problems Hypoglycemia (1912); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2022

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The investigation was performed on the user's data available in data management system.Based on the investigation analysis, there was an issue with syncing the user glucose data to dms.Due to this issue the reported event could not be confirmed and investigated at this time.At the time of the investigation analysis, the syncing issue was resolved by creating a new dms account, but by then the user was inserted with a new sensor (265005) on (b)(6) 2022 and as a result the old sensor (241934) data could not be retrieved for further analysis.

Event Description

Senseonics was made aware of a false hypoglycemia event and complained of sensor inaccuracies.User reported that the event happened on 26 april 2022 and provided and mentioned that the sensor glucose reading was 54 mg/dl where as blood glucose (bg) reading was 129 mg/dl (normal).User was not symptomatic, but still received low glucose alerts.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876-7005
• MDR Report Key: 19008754
• MDR Text Key: 338980137
• Report Number: 3009862700-2024-00338
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/29/2024

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: 02/04/2022
• Device Model Number: 102208-005
• Device Catalogue Number: FG-3400-50-001
• Device Lot Number: 122465
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2022
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other