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

Model Number 102096-67A

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2019 senseonics was made aware of an event where the sensor broke into two pieces before the removal procedure.Both pieces of the sensor was removed during the initial removal procedure.

Manufacturer Narrative

Manufacturers narrative is updated to: all fragments of the broken sensor were removed on (b)(6) 2019.The patient was doing fine afterwards.The definitive root cause could not be determined for the sensor breakage.Based on the case notes, it is possible that the patient sustained an impact to the insertion site even though no trauma was reported.It is also possible that the hcp unknowingly broke the sensor during the removal procedure.Spontaneous breakage is exceedingly unlikely.

Manufacturer Narrative

Both the pieces of sensor were broken and removed prior to removal on (b)(6) 2019.The patient was doing fine.No further investigation is required.H6 results code updated to 3221.H6 conclusion code updated to 4311.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• MDR Report Key: 9581143
• MDR Text Key: 183547571
• Report Number: 3009862700-2020-00013
• 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,Followup
• Report Date: 12/13/2019

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: 03/19/2020
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP05901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 12/13/2019; 12/13/2019
• Supplement Dates FDA Received: 02/25/2020; 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR