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

Model Number 102208-500

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

The malfunction was confirmed.This issue is being analyzed under corrective and preventive action.

Event Description

On (b)(6) 2020,senseonics was made aware of an incident event where user transmitter blew up on the charger when placed for charging.

Manufacturer Narrative

B5.Event description corrected to "on september 01st 2020,senseonics was made aware of an incident event where user transmitter blew up on the charger when placed for charging".

Manufacturer Narrative

Transmitter battery was found to be defective.Capa-0109 addresses the manufacturing changes related to handling of battery and capa-0109 resolution will apply to this case.Further root cause investigation of this issue is detailed in rep-1836.D9 device returned to manufacturer date updated 10/05/2020.H3.Device evaluated by manufacturer? no, device problem already known, no evaluation necessary.H6.Investigation findings updated to 131.

• 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: 10617551
• MDR Text Key: 212479554
• Report Number: 3009862700-2020-00505
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021441
• UDI-Public: 00817491021441
• Combination Product (y/n): Y
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/08/2020
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 113086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Date Manufacturer Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR