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

Model Number	102096-67A
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is result of a retrospective review of complaints.The sensor was replaced and returned for analysis.The malfunction was confirmed.
Event or Problem Description
On (b)(6) 2019, senseonics was made aware of a situation where a device is to be removed early due to sensor inaccuracy.

• Brand Name: EVERSENSE SENSOR
• Common Device Name: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown, md
• MDR Report Key: 9944386
• Report Number: 3009862700-2020-00256
• Device Sequence Number: 11577727
• Product Code: QCD
• UDI-Device Identifier: 00817491021410
• UDI-Public: 00817491021410
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2019

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
• Operator of Device: No Information
• Device Expiration Date: 03/07/2019
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP04530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR