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

Model Number 102208-904

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 11/18/2023

Event Type  Injury  

Event Description

Senseonics was made aware of a hypoglycemia event and where the user reported inaccurate glucose readings and not receiving low glucose alerts from the device.The user reported the sensor glucose (sg) reading was 96 mg/dl where as the measured blood glucose (bg) value was 43 mg/dl.The system did not alert any low glucose alerts because the sg reading did not cross below the low alert threshold which was set at 70 mg/dl.The user self resolved the incident by eating two apples and drinking glucose.The user did not seek any medical attention.

Manufacturer Narrative

Manufacturer is currently performing evaluation and the results will be provided in the supplemental report.

Manufacturer Narrative

User reported a hypoglycemic event on the 18-nov-2023 at 1:39 am with sg=96 mg/dl and bg=43 mg/dl.Upon review of the data on dms, sg=96 mg/dl at 1.39 am on (b)(6) 2023 and bg=43 mg/dl, for which bg marked as suspicious fingerstick at 1.44 am on (b)(6) 2023.Based on the investigation analysis, the reported event at 1.39 am on (b)(6) 2023, was confirmed.Further analysis of the associated pm1 salesforce case # (b)(4), it was reported that there was hematoma and swelling around the insertion site at the time of the reported event (b)(6) 2023.This reported incident of hematoma and swelling around the insertion site most likely affected the performance of the sensor at the time.Once the insertion site healed, the sensor began performing within expectations and displayed better agreement between the sensor readings and calibration entries.The user is currently using the system and has confirmed the system is recovering and working within expectations.B4.Date of report updated to 01/11/2024.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 4315.

• 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: 18404704
• MDR Text Key: 331475533
• Report Number: 3009862700-2023-00840
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491023384
• UDI-Public: 817491023384
• 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,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/02/2024
• Device Model Number: 102208-904
• Device Catalogue Number: FG-3500-04-001
• Device Lot Number: 134895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2023
• 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