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

Model Number	50-10020
Health Effect - Clinical Codes	Death (1802); Dyspnea (1816); Fatigue (1849); Hypoxia (1918); Nausea (1970); Chills (2191); Test Result (2695); Cough (4457)
Date of Event	01/08/2021
Type of Reportable Event	Death
Additional 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 or Problem 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
• Common Device Name: ARIES® FLU A/B & RSV ASSAY
• Manufacturer (Section D): LUMINEX CORPORATION; 12212 technology blvd #130; austin TX 78727
• MDR Report Key: 11231005
• Report Number: 1650733-2021-00002
• Device Sequence Number: 17109106
• Product Code: OCC
• UDI-Device Identifier: 00840487100158
• UDI-Public: 00840487100158
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death