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 05/26/2020

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 multiple high ambient light alerts leading to sensor removal and replacement.

Manufacturer Narrative

The sensor was investigated.The customer complaint was not confirmed by in-vitro qc testing and investigation showed that sensor performed as expected both in-vivo and in-vitro.The investigations shows that system correctly triggered ambient light alerts as signal off and reference off channels jumped by more than 4 adc counts.The system correctly temporarily blinded glucose values as a failsafe mechanism and the system's self-test functions are working normally.D8 updated,was this device serviced by a third party? no d9 device available for evaluation? yes, device received on 07/21/2020.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 2917 h6.Component code updated to 510 h6.Type of investigation updated to 4111 and 10 h6.Investigation findings updated to 213 h6.Investigation conclusions updated to 67.

• 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: 10195609
• MDR Text Key: 196474686
• Report Number: 3009862700-2020-00371
• 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: 05/26/2020

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: 09/06/2020
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP07462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 05/26/2020
• Supplement Dates FDA Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR