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

Model Number 50-10020

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

Patient Problems Death (1802); Dyspnea (1816); Fever (1858); Low Blood Pressure/ Hypotension (1914); Pneumonia (2011); Sepsis (2067); Weakness (2145)

Event Date 12/22/2020

Event Type  Death  

Manufacturer Narrative

Based on the investigation completed at this time, there is no indication of device malfunction.The event is also being investigated separately under escalation case (b)(4).

Event Description

Customer reported a discrepancy results for influenza b on aries flu a/b and rsv assay.Aries: influenza b positive.Sample was not repeated on aries.Confirmation testing, (b)(6) public health lab pcr state (multiplex rt pcr): influenza b negative.The patient was admitted due to fever, chills, sob, weakness, hypotension, pneumonia, sepsis.The aries flu b result was released to the physician on (b)(6) 2020 @ 1959.The patient was receiving following the treatments prior to aries result, azithromycin, vancomycin, zosyn; the addition of tamiflu was added after the aries result was released.The sample was not stored before testing on the aries.This patient's sample came to the laboratory from the emergency department and was tested immediately on demand (it was ordered stat).On (b)(6) 2020, sample ran on aries (b)(4) module a position a4 run: ariesk1-run#493-a sample id (b)(6) result: influenza a negative, rsv negative, influenza b positive (ct= 39.4 tm= 78.6).The sample was stored refrigerated prior to testing at (b)(6) public health lab and resulted as a flu b negative.Qc was ran on the aries instrument 9 hours prior on a4 and was successful.Date/time of expiry: (b)(6) 2020 @ 0554, cause of patient death: klebsiella pneumoniae severe sepsis secondary to bilateral pneumonia.

Manufacturer Narrative

This follow up #001 for 1650733-2021-00001 is to correct the date of event (section b3) to on (b)(6) 2020.

• 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; austin TX 78727
• MDR Report Key: 11181405
• MDR Text Key: 227724890
• Report Number: 1650733-2021-00001
• Device Sequence Number: 1
• Product Code: OCC
• UDI-Device Identifier: 00840487100158
• UDI-Public: 00840487100158
• Combination Product (y/n): N
• PMA/PMN Number: K161220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• 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
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death