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

Model Number 102208-500

Device Problem Device Alarm System (1012)

Patient Problem Hyperglycemia (1905)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On october 14th, 2019 senseonics was made aware of an adverse event where the user experienced a hyperglycemia event and reported the continuous glucose monitoring system did not alert her for the hyperglycemia event.

Manufacturer Narrative

Based on the investigation, the fingerstick calibration entries were not done correctly prior to the incident and as a result system displayed glucose based on those calibration.Once system detected the differences in calibration pattern, it asserted the sensor suspend and the system was unavailable for use for 6 hours.After 6 hours, the system was back in initialization and started displaying glucose to the new calibration entries.It was concluded that there was no malfunction with the continuous glucose monitoring (cgm).G1,2 contact information was updated h6 results code was updated to 213.H6 conclusion code was updated to 19.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC; 20451 seneca meadows parkway; germantown MD 20876 7005
• MDR Report Key: 9305802
• MDR Text Key: 167347163
• Report Number: 3009862700-2019-00305
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

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: 03/29/2020
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 112944
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 11/11/2019
• Supplement Dates Manufacturer Received: 10/14/2019
• Supplement Dates FDA Received: 07/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR