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

Model Number 102096-67A

Device Problem Insufficient Information (3190)

Patient Problem Hypoglycemia (1912)

Event Date 08/02/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2019, senseonics was made aware of an adverse event where the user experienced a hypoglycemia event.The user did not require medical attention.

Manufacturer Narrative

This mdr is result of a retrospective review of complaints.Per case notes, transmitter was removed before the time of the event due to alarm fatigue and user requested not to be contacted by the hcp.The system was not operating during the hypo event.No further investigation is needed.H6 method code updated to 4114.H6 result code updated to 3221.H6 conclusion code updated to 67.

• Brand Name: EVERSENSE SENSOR
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC; 20451 seneca meadows parkway; germantown MD 20876 7005
• MDR Report Key: 8958251
• MDR Text Key: 156907484
• Report Number: 3009862700-2019-00079
• 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: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/03/2020
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP05492
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR