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

Model Number 102208-705

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 10/01/2020

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 the hypo alert at 9:09 pm cet on (b)(6) which is after 9 pm cet as reported in the case notes.There was no system malfunction.

Event Description

On october 2, 2020, senseonics was made aware of an instance where patient experienced hypoglycemia event on (b)(6) 2020.Patient reported that before dinner she performed the calibration (around 20.30) and the blood glucose (bg) level was stable at 146 mg / dl; but after dinner (around 21.00) she felt bad and noticed that eversense was showing a reading of 90/100 mg / dl, while accu chek solo was giving 46 mg / dl.Patient had a severe hypoglycemic crisis and was helped by her husband and mother who gave her some sugar and water.Now the patient is fine.

• 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: 18965293
• MDR Text Key: 338431679
• Report Number: 3009862700-2024-00151
• Device Sequence Number: 1
• Product Code: QHJ
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/08/2020
• Device Model Number: 102208-705
• Device Catalogue Number: FG-3400-05-001
• Device Lot Number: 116320
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2019
• 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