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

Model Number 102096-67A

Device Problem Device Sensing Problem (2917)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020, senseonics was made aware of an instance where patient experienced low sensor temperature alerts leading to sensor removal and replacement.

Manufacturer Narrative

The customer complaint was confirmed by review of in-vivo data.The sensor did not communicate during tests in lab despite repeated efforts.The likely root cause of issue is damage to asic chip potentially resulting from sensor kept much higher than specified storage temperature conditions at health care professional.D8 updated,was this device serviced by a third party? no d9 device returned to manufacturer date updated to: 27 august 2020.H3 device evaluated by manufacturer?yes health effect - clinical code updated to 4582 health effect -impact code updated to 2199 medical device problem code updated to 2917 component code updated to 510 type of investigation updated to 4111 investigation findings updated to 4203 investigation conclusions updated to 4307.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown, md
• MDR Report Key: 10373004
• MDR Text Key: 201944459
• Report Number: 3009862700-2020-00454
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/16/2020
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP07576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 07/08/2020
• Supplement Dates FDA Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR