MAUDE Adverse Event Report: LUMINEX MOLECULAR DIAGNOSTICS, INC. NXTAG RESPIRATORY PATHOGEN PANEL + SARS-COV-2

Catalog Number I056C0468

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

In review of all case details against the criteria set forth in document (b)(4) (medical device reporting standard operating procedure) and its applicable appendices, this complaint does not meet the requirements for an mdr in the countries where the device is sold or distributed.However, the mdr is being submitted to us fda pursuant to the obligations of the emergency use authorization, and per communication received from fda on october 7, 2020.

Event Description

The customer reported that they have a sample which generated an invalid result, and upon repeat from extraction, it generated 7 pos calls (including flu a and flu b).The third repeat from a new extraction generated an invalid result.The sample in question was run on an alternate assay (genmark) and it generated a neg call.

• Brand Name: NXTAG RESPIRATORY PATHOGEN PANEL + SARS-COV-2
• Type of Device: NXTAG RESPIRATORY PATHOGEN PANEL + SARS-COV-2
• Manufacturer (Section D): LUMINEX MOLECULAR DIAGNOSTICS, INC.; 439 university ave; toronto, ontario M5G1Y 8; CA M5G1Y8
• Manufacturer Contact: wendy ricker ; 12212 technology blvd suite 13; austin, TX 78727
• MDR Report Key: 12274373
• MDR Text Key: 267230667
• Report Number: 3002777243-2021-00012
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: I056C0468
• Device Lot Number: IK056C-0003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1