FDA Adverse Event Malfunction Summary report: N

EVERSENSE SENSOR

MDR report key: 11989164 · Received June 13, 2021

Report

Report Number: 3009862700-2021-00082
Event Type: Malfunction
Date Received: June 13, 2021
Date of Event: May 13, 2021
Report Date: May 14, 2021
Manufacturer: SENSEONICS INC.
Product Code: QCD
UDI-DI: 00817491022349
PMA / PMN Number: P160048
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THE SENSOR WAS INVESTIGATED, AND CUSTOMER COMPLAINT WAS CONFIRMED DURING REVIEW OF IN-VIVO DATA. THE ROOT CAUSE OF THE ISSUE (I.E. NOISE IN GLUCOSE VALUES) WAS CONFIRMED DURING REVIEW OF THE DMS LOGS AS WELL AS DURING IN-HOUSE QC. THE ROOT CAUSE OF NOISE WAS FOUND TO BE DAMAGED LED/LED DISCONNECT. THE INVESTIGATION SHOWS THE SYSTEM CORRECTLY DISABLED THE SENSOR DUE TO PERFORMANCE FAILURE AND THE SYSTEM'S SELF-TEST FUNCTIONS ARE WORKING NORMALLY.AS PART OF RESOLUTION, THE RMA WAS AUTHORIZED TO OFFER THE USER A SENSOR REPLACEMENT. D9 DEVICE AVAILABLE FOR EVALUATION? YES, DEVICE RECEIVED ON 18 JUNE 2021. H3. DEVICE EVALUATED BY MANUFACTURER? YES. H6. TYPE OF INVESTIGATION UPDATED TO 10. H6. INVESTIGATION FINDINGS UPDATED TO 4203. H6. INVESTIGATION CONCLUSIONS UPDATED TO 4307.

Additional Manufacturer Narrative · 1

THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.

Description of Event or Problem · 1

ON (B)(6) 2021,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER RECEIVED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
885533	EVERSENSE SENSOR	EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM	QCD	SENSEONICS INC.	102096-67A	WP07834	00817491022349

Patients

Seq	Age	Sex	Outcome	Treatment
1	39 YR