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

Device Problem Insufficient Information (3190)

Patient Problem Loss of consciousness (2418)

Event Date 06/24/2021

Event Type  Injury  

Manufacturer Narrative

User became unconscious and fell down on the floor at his home and then hospitalized for 8 days due to eversense continuous glucose monitor system.Despite multiple follow up attempts with the user no more information could be gathered since the customer refused to continue with the call.No additional information will be provided by user, reviewed data management system and there is no data available.

Event Description

On june 25th 2021, senseonics was made aware of an adverse event when patient became unconscious and fell down on the floor at his home and then hospitalized for 8 days due to eversense continuous glucose monitor system.Despite multiple follow up attempts with the user no more information could be gathered since the customer refused to continue with the call.

• 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: 12214325
• MDR Text Key: 263146302
• Report Number: 3009862700-2021-00094
• Device Sequence Number: 1
• Product Code: QCD
• 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
• Report Date: 06/25/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/22/2021
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 78 YR