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

Model Number 102208-904

Device Problem Communication or Transmission Problem (2896)

Patient Problem Hypoglycemia (1912)

Event Date 03/03/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The preliminary investigation was performed on the user synced glucose data on data management system (dms), which is an eversense cloud platform.The preliminary investigation analysis could not confirm the customer complaint as the customer did not enter the reported blood glucose (bg) value of 23 mg/dl into the system as calibration.A review of the alert history revealed that on (b)(6) 2023 the system asserted 4 consecutive low glucose alerts, starting at 8:34pm, repeating every 10 minutes, until 9:04pm.According to the user, the alerts were not felt as she was asleep.Although, the system asserted appropriate alerts, the customer decided to discontinue using the system.As a result, a return material authorization (rma) was issued to bring the transmitter for further investigation.The investigation of the returned transmitter did not reveal any malfunction as it passed all the functional tests including the vibration tests.The vibrations from the transmitter felt normal and as expected.The customer complaint could not be confirmed and no further investigation was found necessary for this complaint.The most likely root cause of the incident can be attributed to customer sleeping at the time of incident.The customer would have likely not perceived or felt the alerts at the time of incident.

Event Description

Senseonics was made aware of a serious adverse event where the patient / customer lost consciousness due to a hypoglycemia.The incident occurred on (b)(6) 2023 and her husband treated with glucose.It was reported that the sensor glucose (sg) reading was 42 mg/dl at 08:50 pm and the blood glucose (bg) reading was 23 mg/dl.The patient was not sure whether she received the alert at the time of incident or not because she was asleep 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: 18116935
• MDR Text Key: 327886118
• Report Number: 3009862700-2023-00224
• Device Sequence Number: 1
• Product Code: QHJ
• 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: 11/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/30/2023
• Device Model Number: 102208-904
• Device Catalogue Number: FG-3500-04-001
• Device Lot Number: 132065
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2022
• 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