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

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

This mdr is result of a retrospective review of complaints.Ultrasound was used to locate the sensor, but no sensor was seen in either of the user's arm.No clear root cause could be determined, however, it is likely that the sensor was never inserted in the first place possibly due to procedural error and/or insertion tool malfunction, which includes but not limited to sensor not being properly loaded into the insertion tool or not being unloaded from the insertion tool into the insertion pocket.Per dms, a new sensor was inserted into the user on (b)(6) 2020.No further investigation was possible as no material was available to investigate.

Event Description

On (b)(6) 2019,senseonics was made aware of an incident where user was not able to find his sensor and unable to find the signal.Ultrasound was used to locate the sensor, but no sensor was seen in either of the user's arm.

• 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: 9998666
• MDR Text Key: 188999469
• Report Number: 3009862700-2020-00258
• Device Sequence Number: 1
• Product Code: QCD
• 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: 12/12/2019

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 04/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 23 YR