MAUDE Adverse Event Report: LUMINEX CORPORATION ARIES SARS-COV-2 ASSAY

Model Number N/A

Device Problem Lack of Maintenance Documentation or Guidelines (2971)

Patient Problem Insufficient Information (4580)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

Aries sars-cov-2 validation testing.Molecular application specialist (mas) required documentation of the validation testing that is on-going at (b)(6) medical center.

• Brand Name: ARIES SARS-COV-2 ASSAY
• Type of Device: ARIES SARS-COV-2 ASSAY
• Manufacturer (Section D): LUMINEX CORPORATION; 12212 technology blvd; suite 130; austin TX 78727
• Manufacturer Contact: wendy ricker ; 12212 technology blvd.; austin, TX 78727 ; 6082038936
• MDR Report Key: 10873113
• MDR Text Key: 218553200
• Report Number: 1650733-2020-00024
• Device Sequence Number: 1
• Product Code: QJR
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2021
• Device Model Number: N/A
• Device Catalogue Number: 50-10026
• Device Lot Number: AB0630A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2020
• 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