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

Model Number 102208-905

Device Problem Imprecision (1307)

Patient Problems Headache (1880); Hypoglycemia (1912)

Event Date 05/06/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The investigation was performed on the user synced glucose data on data management system (dms), which is an eversense cloud platform.Based on the investigation analysis, the reported sg value of 150 mg/dl at the time of incident could not be confirmed.Per dms, the sg value was 166 mg/dl at 5:31 pm and the bg fingerstick value of 185 mg/dl was entered at 5:40 pm.No high glucose alert was asserted during the time of incident as the sg value did not cross the high alert threshold that was set at 170 mg/dl.The investigation analysis did not reveal any malfunction as the overall system performance was within expectations.Overall, bg values entered as calibrations fit sg trends well and the occasional differences could be attributed to lag which is inherent to cgm system, and due to calibrations that were entered during the periods of rapid glucose changes.The eversense user guide recommends users to avoid calibrations during the period of rapid glucose changes.No further investigation was found necessary for this complaint.

Event Description

Senseonics was made aware of a customer experiencing a hypoglycemia events on (b)(6) 2023 at 5:33 pm.The customer reported that the measured blood glucose (bg) value was 185 mg/dl where as the sensor glucose (sg) reading was 150 mg/dl.The customer did not receive low glucose alert because the sg value did not cross above the high alert threshold which was set at 170 mg/dl.The customer had symptom of headache at the time of incident.

• 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: 18117301
• MDR Text Key: 327880199
• Report Number: 3009862700-2023-00267
• 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: 11/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/07/2023
• Device Model Number: 102208-905
• Device Catalogue Number: FG-3500-05-001
• Device Lot Number: 133445
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2022
• 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