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

Model Number N/A

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

Patient Problem Test Result (2695)

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The customer's molecular applications specialist (mas) has reported a negative aries sars-cov-2 result when running in comparison with their cepheid system which reported a positive result.This patient sample was used for quality control on the aries system.Aries: not detected cepheid: detected run results received: 1st run: specimen 1 cepheid ct values e gene=33.7 n2 gene=36.5 aries ct=nd.Specimen 2 cepheid ct values e gene =30.6 n2 gene= 33.7 aries ct= nd.2nd run: specimen 1 cepheid ct values e gene=31.4 n2 gene=34.2 aries ct=nd.Specimen 2 cepheid ct values e gene =30.2 n2 gene= 33.2 aries ct= n=37.6.

• 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: 10873114
• MDR Text Key: 218517202
• Report Number: 1650733-2020-00022
• 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 Model Number: N/A
• Device Catalogue Number: 50-10047
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2020
• 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