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

Model Number 101368-67A

Device Problem Imprecision (1307)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2019

Event Type  malfunction  

Event Description

On march 20, 2019, senseonics was made aware of an incident where the user said that the readings were inaccurate.The user received readings of 4.2 mmol/l at 14:00 on (b)(6) 2019 compared to the blood glucose reading which were 9.2 mmol/l.

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.The sensor was removed and returned for investigation.After receiving the sensor in-house, a visual inspection was done, and no anomalies were observed.Next, the investigation of the sensor was performed, the analysis done in the lab indicated that the sensor had a reduction in responsivity to glucose due to oxidation of the glucose sensing indicator molecule.The reported variations between bg and cgm were on (b)(6).The variance between bgm and cgm occurs either due to localized rapid drop in sensor responsivity or bad finger stick entries made at that time.

• Brand Name: EVERSENSE SENSOR
• 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: 19009460
• MDR Text Key: 339009239
• Report Number: 3009862700-2024-00108
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/20/2018
• Device Model Number: 101368-67A
• Device Catalogue Number: FG-4400-XX-302
• Device Lot Number: WP04105
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 03/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2018
• 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