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

Model Number 102096-67A

Device Problem Difficult to Remove (1528)

Patient Problem Discomfort (2330)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Event Description

On november 21st, 2019, senseonics was made aware of an incident where the physician was unable to explant the eversense sensor on the first attempt made on (b)(6) 2019.

Manufacturer Narrative

No response was received after multiple attempts; thus status of sensor removal could not be confirmed.H3.Device evaluated by manufacturer? no h6.Health effect - clinical code updated to 2330 h6.Health effect -impact code updated to 4614 h6.Medical device problem code updated to 1528 h6.Component code updated to 510 h6.Type of investigation updated to 4111 h6.Investigation findings updated to 3221 h6.Investigation conclusions updated to 67.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• MDR Report Key: 9504020
• MDR Text Key: 177964228
• Report Number: 3009862700-2019-00358
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491022349
• UDI-Public: 00817491022349
• Combination Product (y/n): N
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

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
• Device Expiration Date: 05/02/2020
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP06323
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 11/21/2019
• Supplement Dates FDA Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR