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

Model Number 102208-500

Device Problem Device Alarm System (1012)

Patient Problem Hypoglycemia (1912)

Event Date 10/17/2019

Event Type  Injury  

Manufacturer Narrative

Investigation revealed no malfunction in the system.The system performed as expected.

Event Description

On (b)(4) 2019, senseonics was made aware of on incident where the user experienced a hypoglycemia event and the eversense cgm system did not alert the user.

• 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: sachin thanawala ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 9327723
• MDR Text Key: 166537722
• Report Number: 3009862700-2019-00308
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021441
• UDI-Public: 00817491021441
• Combination Product (y/n): N
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2020
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 112916
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2019
• 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: 54 YR