FDA Adverse Event Malfunction Summary report: N

NXTAG COV EXTENDED PANEL

MDR report key: 12021071 · Received June 17, 2021

Report

Report Number: 3002777243-2021-00001
Event Type: Malfunction
Date Received: June 17, 2021
Date of Event: January 12, 2021
Report Date: May 19, 2021
Manufacturer: LUMINEX MOLECULAR DIAGNOSTICS, INC.
Product Code: QJR
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THERE WAS NO REPORTED INJURY OR DEATH AT THE TIME OF THIS REPORT. THE MDR IS BEING SUBMITTED UNDER DEVIATION (B)(4) PURSUANT TO THE OBLIGATIONS OF THE EMERGENCY USE AUTHORIZATION, AND PER COMMUNICATION RECEIVED FROM FDA ON OCTOBER 7, 2020.

Description of Event or Problem · 1

THE CUSTOMER, (B)(6) UNIVERSITY HEALTH, REPORTED SEVERAL NEGATIVE CONTROL FAILURES FOR NXTAG COV EXTENDED PANEL (LOT# IK054C-0012) RUNNING ON THE MAGPIX INSTRUMENT. THE CUSTOMER LATER INFORMED TECHNICAL SUPPORT THAT THEY PERFORMED A SWIPE TEST AND APPARENTLY THE POST AREA CAME UP POSITIVE FOR SARS-COV-2, SO THEY CUSTOMER CLEANED THE THERMOCYCLERS AND MAGPIX. THE CUSTOMER WILL INCREASE THEIR FREQUENCY OF CLEANING. TECHNICAL SUPPORT FORWARDED TO THE CUSTOMER MAS TROUBLESHOOTING RECOMMENDATION WHICH WILL HELP RESOLVE ANY POSSIBILITY OF CONTAMINATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
918624	NXTAG COV EXTENDED PANEL	NXTAG COV EXTENDED PANEL	QJR	LUMINEX MOLECULAR DIAGNOSTICS, INC.		IK054C-0012

Patients

Seq	Age	Sex	Outcome	Treatment
1