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

Model Number 102096-67A

Device Problem Imprecision (1307)

Patient Problem No Code Available (3191)

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

User declined receiving assistance from the customer care as she had decided to get her sensor removed.Hence, no investigation/troubleshooting was possible for this complaint.

Event Description

On (b)(6) 2020,senseonics was made aware of an incident where user experienced inaccuracies in sensor readings and wanted to get the sensor removed.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown, md
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown, md
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, md
• MDR Report Key: 10418567
• MDR Text Key: 203290621
• Report Number: 3009862700-2020-00442
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2020

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: 09/20/2020
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP07468
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 21 YR