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

Model Number 102096-67A

Device Problem Intermittent Communication Failure (4038)

Patient Problem Discomfort (2330)

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

The user registered an excellent signal on the transmitter with the new sensor.

Event Description

On (b)(6) 2019, senseonics was made aware of an incident where the sensor was removed due to poor communication (weak signal) between the transmitter and the sensor.

• Brand Name: EVERSENSE SENSOR
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• 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 ; 3015561625
• MDR Report Key: 9183704
• MDR Text Key: 162999588
• Report Number: 3009862700-2019-00148
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491022349
• UDI-Public: 00817491022349
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/05/2019
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP05299
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 36 YR