MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SMART TRANSMITTER; IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER

Model Number 102208-005

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 01/16/2022

Event Type  Injury  

Event Description

Senseonics was made aware of a hyperglycemia event due to alleged sensor inaccuracies on (b)(6) 2021 at around 6:00 pm.The reported blood glucose (bg) value was 330 mg/dl and sensor glucose (sg) value was 120 mg/dl.User did not receive high glucose alerts because the sg value never crossed the set high alert threshold of 200 mg/dl.User wasn't symptomatic, didn't seek medical treatment and managed the hyperglycemia herself by injecting insulin.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Transmitter was not requested to be returned for evaluation as it was still being used by the user.The investigation was based on the user's data available in data management system (dms).The investigation confirmed the mismatch between bg and sg on (b)(6) 2022 as reported.The sensor had just been inserted four days prior to the incident, on (b)(6) 2022.Although, the exact root cause of the variation could not be determined, the most likely root cause can be attributed to early wear when the sensor is still getting adjusted to the body.The variation can happen sometimes due to bruise or the wound around the insertion area.A review of the data in a 2-week time range and beyond didn't reveal any malfunction of the sensor.

• Brand Name: EVERSENSE SMART TRANSMITTER
• Type of Device: IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER
• 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: 19009354
• MDR Text Key: 338980536
• Report Number: 3009862700-2024-00318
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• 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: 03/31/2024

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: 02/10/2022
• Device Model Number: 102208-005
• Device Catalogue Number: FG-3400-50-001
• Device Lot Number: 122560
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 03/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2021
• 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): Other