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

Model Number 102096-67A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 06/28/2019

Event Type  Injury  

Manufacturer Narrative

After having the sensor removed, the user noticed blood forming under his tegaderm and subsequently visited the urgent care clinic two hours later.The healthcare professional at the urgent care clinic cleaned the incision and noticed the incision was completely open and stitched the incision.Later, the user spoke with his healthcare professional who removed the sensor and was told by his healthcare professional that the bleeding may have resulted from sensor being encapsulated making it difficult to remove.The healthcare professional also stated that he should have used some type of compression bandage although they did not have any at the time of the sensor removal procedure.As of (b)(6) 2019 the user reported he was ok and the wound was no longer bleeding since being treated with the stitches at the urgent care clinic.

Event Description

On (b)(6) 2019 senseonics was made aware of an event where a user experienced excessive bleeding after a sensor removal procedure.The user subsequently went to another healthcare professional due to the bleeding and had to get stitches on his incision site to stop the bleeding and was not prescribed any medication.

• Brand Name: EVERSENSE SENSOR
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): SENSEONICS INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: anglea bandy ; 20451 seneca meadows parkway; germantown, MD 20876-7005 ; 3014072878
• MDR Report Key: 8844235
• MDR Text Key: 152753456
• Report Number: 3009862700-2019-00052
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021410
• UDI-Public: 00817491021410
• 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: 06/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/29/2019
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: WP04605
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2019
• Initial Date FDA Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2018
• 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 Outcome(s): Other
• Patient Age: 50 YR