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	04/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is result of a retrospective review of complaints.Sensor was removed from the patient and sent to manufacturer for evaluation.Investigation results revealed that sensor performed as expected.There was no malfunction with the device.Complaint cannot be confirmed.
Event or Problem Description
On (b)(6) 2019, senseonics was made aware of an incident where the patient experienced unstable sensor readings and the sensor glucose readings having lot of variability.

• 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: 9975852
• Report Number: 3009862700-2020-00289
• Device Sequence Number: 19695049
• 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
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/23/2019
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP04597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR