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

Model Number 102208-500

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 03/24/2022

Event Type  Injury  

Manufacturer Narrative

The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Event Description

On 01 april 2022, senseonics was made aware of an incident where the user went to the emergency room due to an episode of low glucose levels.

Manufacturer Narrative

It was reported that the user's sensor would not read above 42 mg/dl and hence visited emergency room (er).User was put under observation and the glucose level reached 80's (mg/dl) about an hour later.No specific information like sensor and blood glucose values, and the time of the incident, are available to conduct further investigation.Those information could not be gathered due to lack of response from the user.H6.Investigation findings updated to 3221.H6.Investigation conclusion updated to 67.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20875-7005
• MDR Report Key: 14268971
• MDR Text Key: 290574595
• Report Number: 3009862700-2022-00062
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491021441
• UDI-Public: 00817491021441
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/27/2022
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 123772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/27/2021
• 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
• Patient Age: 78 YR
• Patient Sex: Female