MAUDE Adverse Event Report: SENSEONICS INC EVERSENSE TRANSMITTER; CONTINOUS GLUCOSE MONITOR

Model Number 102208-500

Device Problem Failure to Charge (1085)

Patient Problem Hyperglycemia (1905)

Event Date 07/12/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On july 29, 2019 senseonics was made aware of an adverse event where the user experienced a hyperglycemia event (dka) that required hospitalization.The user was not wearing the continous glucose monitoring system at the time as the smart transmitter was being charged.

Manufacturer Narrative

User did not charge the device and hence was not wearing the device at the time of the hyperglycemia event which led to user not receiving the glucose alerts.G1-2 contact information was updated, h6 results code was updated to 3221, h6 conclusions code was updated to 19.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: CONTINOUS GLUCOSE MONITOR
• Manufacturer (Section D): SENSEONICS INC; 20451 seneca meadows parkway; germantown MD 20876 7005
• MDR Report Key: 8942372
• MDR Text Key: 156282025
• Report Number: 3009862700-2019-00067
• 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: 07/29/2019

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?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/14/2019
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 110713
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/28/2019
• Supplement Dates Manufacturer Received: 07/29/2019
• Supplement Dates FDA Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 21 YR