FDA Adverse Event Malfunction Summary report: N

NXTAG COV EXTENDED PANEL

MDR report key: 12021088 · Received June 17, 2021

Report

Report Number: 3002777243-2021-00003
Event Type: Malfunction
Date Received: June 17, 2021
Date of Event: April 29, 2020
Report Date: June 15, 2021
Manufacturer: LUMINEX MOLECULAR DIAGNOSTICS, INC.
Product Code: QJR
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NJ, 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

ON (B)(6) 2020, THE CUSTOMER REPORTED THAT THEY HAVE BEEN GETTING ALL POSITIVES ON THEIR RUNS. TECHNICAL SUPPORT REQUESTED THE INSTRUMENT SERIAL NUMBER, LOT NUMBERS AND RAW DATA FILES FROM THE CUSTOMER. CUSTOMER REPEATED RUNS ON ROTAGENE WHICH IS A CLOSED SYSTEM AND ALL SAMPLES REPORTED CORRECT RESULTS, BUT ALL 96 SAMPLES WERE POSITIVES ON MAGPIX. THIS STARTED ON (B)(6). CUSTOMER REPEATED RUN AGAIN WITH 48 SAMPLES LEAVING STRIPS IN BETWEEN. ALL SAMPLES WERE POSITIVE HOWEVER, CONTROLS WORKED FINE AS DESIRED. CUSTOMER CONFIRMED THERE WERE NO PROCESS CHANGES BETWEEN EXTRACTION AND RUNNING SAMPLES ON THE MAGPIX. CUSTOMER HAS TRIED DIFFERENT SETS OF PIPETTES BUT ALL POSITIVES AGAIN. NEC IS FROM THE SAME EXTRACTION AND IT IS CLEAN. NTC IS ALSO CLEAN BUT THIS IS JUST WATER. LUMINEX MAS DIRECTOR REVIEWED THE RESULTS AND INDICATED THAT CUSTOMER HAS PROBABLY CONTAMINATED THEIR EXTRACTION SYSTEM OR REAGENTS/AREA/EQUIPMENT. ALSO, IT WAS DETERMINED THAT THEY ARE TREATING NEC DIFFERENT THAN SAMPLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
918625	NXTAG COV EXTENDED PANEL	NXTAG COV EXTENDED PANEL	QJR	LUMINEX MOLECULAR DIAGNOSTICS, INC.		IK054C-0007, IK054C-0008

Patients

Seq	Age	Sex	Outcome	Treatment
1