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

Model Number 102208-500

Device Problem Communication or Transmission Problem (2896)

Patient Problem Hypoglycemia (1912)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

The complaint cannot be confirmed since the patient was not wearing the system due to no sensor detected alerts issue.Patient was assisted by giving glucose pills and juice to treat the hypoglycemia.

Event Description

On (b)(6) 2020, senseonics was made aware of an adverse event where patient was found unresponsive due to hypoglycemia.User was not wearing the system due to no sensor detected alerts issue.Hence,the system did not alert the user.The patient was assisted by her mother and sister during the event and was given glucose pills and juice.

• 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: 10693907
• MDR Text Key: 211917715
• Report Number: 3009862700-2020-00518
• Device Sequence Number: 1
• Product Code: QCD
• 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
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/18/2020
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 116512
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2019
• 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 Age: 24 YR