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

Model Number 102208-500

Device Problem Premature Discharge of Battery (1057)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 12/09/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On dec 18th 2019,senseonics was made aware that user was hospitalized for diabetic ketoacidosis and gastroparesis.The user was not wearing the transmitter at that time of the event as the charge wasn't lasting for long time.

Manufacturer Narrative

Per case notes, the customer indicated that he was not wearing the transmitter at the time of the event.Per design, the customer will not receive any high or low glucose alerts if customer is not wearing the transmitter.Case notes indicate that customer was not wearing the transmitter for last 6 weeks since his transmitter would not hold charge.Rma (rma-06351, crec-11862) was authorized for customer's transmitter but not received so no further confirmation or investigation of the complaint is possible.H6 result code updated to 3221.H6 conclusion code updated to 4315.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown, MD 20875 7005
• MDR Report Key: 9634824
• MDR Text Key: 176659834
• Report Number: 3009862700-2020-00046
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021441
• UDI-Public: 00817491021441
• 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: 12/18/2019

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: 12/08/2019
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 111240
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: 12/18/2019
• Supplement Dates FDA Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR