MAUDE Adverse Event Report: LUMINEX CORPORATION ARIES FLU A/B & RSV ASSAY; ARIES® FLU A/B & RSV ASSAY

Model Number 50-10020

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Dyspnea (1816); Fatigue (1849); Hypoxia (1918); Nausea (1970); Chills (2191); Test Result (2695); Cough (4457)

Event Date 01/08/2021

Event Type  Death  

Manufacturer Narrative

The cause of death was confirmed as cardiopulmonary arrest secondary to covid-19 pneumonia and influenza b.The result of the aries® flu a/b & rsv assay was influenza b.Based the fact that the aries result was influenza b and the patient died from influenza b, there is no indication of a false positive result and therefore no product malfunction.

Event Description

Customer reported influenza b positive on aries flu a/b and rsv assay.Aries: influenza b positive sample was not repeated on another platform, there is no discrepancy to report.On 1/22/2021 luminex was made aware that there was a patient death involved the patient tested positive for both covid and flu b, the flu b was resulted from the aries assay.The patient was admitted due to fatigue, sob, cough, chills, nausea, hypoxia.The aries flu b result was released to the physician on (b)(6) 2021 @ 2055.The patient also tested positive for covid off-site a week prior (approx.(b)(6) 2020).Customer did not know which platform was used for covid testing or which genes were detected.The patient was receiving following the treatments prior to aries result, ceftriaxone and doxycycline ((b)(6) 2021), remdesivir ((b)(6) 2021), azithromycin; the addition of tamiflu was added ((b)(6) 2021) after the aries result was released.

• Brand Name: ARIES FLU A/B & RSV ASSAY
• Type of Device: ARIES® FLU A/B & RSV ASSAY
• Manufacturer (Section D): LUMINEX CORPORATION; 12212 technology blvd #130; austin TX 78727
• Manufacturer Contact: wendy ricker ; 12212 technology blvd; austin, TX 78727 ; 6082038936
• MDR Report Key: 11231005
• MDR Text Key: 228710447
• Report Number: 1650733-2021-00002
• Device Sequence Number: 1
• Product Code: OCC
• UDI-Device Identifier: 00840487100158
• UDI-Public: 00840487100158
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/10/2021
• Device Model Number: 50-10020
• Device Catalogue Number: 50-10020
• Device Lot Number: AB1226A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death