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

Model Number 102096-67A

Device Problem Imprecision (1307)

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

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer is currently performing evaluation and results will be provided with a supplemental report.

Event Description

On (b)(6) 2020,senseonics was made aware of an incident where user experienced inaccuracies in sensor readings resulting in sensor removal.

Manufacturer Narrative

At the time of the initial escalation investigation, it was observed that there was low signal channel modulation and the msp was below the failure threshold of (b)(4).During the initial investigation, due to poor user experience and the low signal modulation and msp being below (b)(4), it was decided to replace the sensor.Per the rma investigation, it was identified that the behavior was due to lack of hydration of the hydrogel in the sensor after insertion.There is no further investigation necessary.D8 was this device serviced by a third party? no.D9 device available for evaluation? yes, device received on 30 july 2020.H3.Device evaluated by manufacturer? yes.H6.Health effect - clinical code updated to 4582.H6.Health effect -impact code updated to 2199.H6.Medical device problem code updated to 1307.H6.Component code updated to 510.H6.Type of investigation updated to 4114 and 10.H6.Investigation findings updated to 3231.H6.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: 10217602
• MDR Text Key: 197162385
• Report Number: 3009862700-2020-00353
• 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: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/29/2020
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP07426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Date Manufacturer Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR