MAUDE Adverse Event Report: SENSEONICS, INCORPORATED EVERSENSE TRANSMITTER; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

Model Number 102208-804

Device Problem Insufficient Information (3190)

Patient Problem Hypoglycemia (1912)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The sensor readings the user mentioned could not be confirmed as no date of event was provided, and no investigation could be performed due to the lack of information.The user, however, reported that low glucose alerts were asserted for both of the hypoglycemic events.Since the deivce asserted the alerts correctly, it functioned as intended.The user mentioned that his wife injected gluocse from an emergency kit during the hypoglycemic events.

Event Description

Senseonics was made aware of an incident where the patient experienced two hypoglycemia events in june 2020.Patient does not remember the exact date and time of the event.However he mentioned that for the first incident, the sensor reading(sg) was 4.6 mmol and blood glucose (bg) reading was below 2 mmol.For the second incident, the sg reading was 3.7 mmol and the bg reading was again below 2 mmol.He had cramps during these incidents and his wife had to inject glucose form an emergency kit.He didn't call a doctor or ambulance.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS, INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS, INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 18488965
• MDR Text Key: 332600891
• Report Number: 3009862700-2023-00494
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/16/2020
• Device Model Number: 102208-804
• Device Catalogue Number: FG-3400-04-101
• Device Lot Number: 13925
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2019
• 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
• Patient Sex: Male