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 02/22/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The investigation analysis was performed on the user synced glucose data on data management system (dms), which is an eversense cloud platform.The investigation analysis could not confirm the reported event, as none of the provided sensor glucose (sg) and corresponding blood glucose (sg) values could be found on the dms for the date of the complaint ((b)(6) 2023).Alert history log shows that all the alerts for glucose values outside of the set threshold were appropriately asserted to the customer.The overall sensor performance , before and after the event, was evaluated and performance was found within expectations.No further investigation was found necessary for this incident.The customer's hcp treated the customer with bacsemi (nose spray) and gluca hypokit.The customer was advised to contact their hcp for any medical assistance.

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 had to call the doctor who lives next door.It was reported that the sensor glucose (sg) reading was 198 mg/dl at 1:46 am and 181 mg/dl at 2:02 am.The blood glucose (bg) reading showed 28 mg/dl.The patient complained of not being alerted by the eversense system.

• 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: 18116768
• MDR Text Key: 327881137
• Report Number: 3009862700-2023-00223
• 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: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• 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: 04/14/2023
• 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): Hospitalization