MAUDE Adverse Event Report: LUMINEX CORPORATION ARIES HSV 1&2 ASSAY

Model Number 50-10017

Device Problems Fluid/Blood Leak (1250); Device Contamination with Body Fluid (2317)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

In review of all associated customer-provided documentation and internally generated investigation notes against the criteria set forth in document (b)(4) (medical device reporting standard operating procedure), this complaint does meet the requirements for an mdr in the countries where aries hsv 1&2 assays are sold or distributed.Implementing guidance received from a recent fda inspection, the associated recall investigation was reassessed on (b)(6) 2021 and the event found to be potentially reportable as a 5 day mdr.This mdr report is submitted within 5 days of 11/4/2021.

Event Description

On (b)(6) 2021 field quality assurance notified regulatory affairs of the customer mayo foundation observing leaks while using aries hsv 1&2 assay - ivd (part number 50-10017, lots ab3600a and ab3560a) following sample runs.The customer reported residue buildup on the actuation block and valve keys of their aries systems.Aries assay cassettes are designed to be a sealed and contained product.Within the cassette, sample preparation and washing utilizes a series of reagents to lyse and purify human dna for pcr analysis.Cassettes that leak while being utilized have the potential to leak the internal reagents and patient sample into the aries system and the aries magazine that loads into the instrument.

Event Description

On september 27, 2021 field quality assurance notified regulatory affairs of the customer (b)(6) observing leaks while using aries hsv 1&2 assay - ivd (part number 50-10017, lots ab3600a and ab3560a) following sample runs.The customer reported residue buildup on the actuation block and valve keys of their aries systems.Aries assay cassettes are designed to be a sealed and contained product.Within the cassette, sample preparation and washing utilizes a series of reagents to lyse and purify human dna for pcr analysis.Cassettes that leak while being utilized have the potential to leak the internal reagents and patient sample into the aries system and the aries magazine that loads into the instrument.

Manufacturer Narrative

In review of all associated customer-provided documentation and internally generated investigation notes against the criteria set forth in document (b)(4) (medical device reporting standard operating procedure), this complaint does meet the requirements for an mdr in the countries where aries hsv 1&2 assays are sold or distributed.Based on the 12/2/21 email from (b)(4), this follow-up 001 report is being submitted to change it from a 5 day report to a 30 day report.

• Brand Name: ARIES HSV 1&2 ASSAY
• Type of Device: ARIES HSV 1&2 ASSAY
• Manufacturer (Section D): LUMINEX CORPORATION; 12212 technology blvd; austin 78727
• Manufacturer Contact: wendy ricker ; 12212 technology blvd; austin, TX 78727
• MDR Report Key: 12753939
• MDR Text Key: 281228082
• Report Number: 1650733-2021-00020
• Device Sequence Number: 1
• Product Code: PGI
• UDI-Device Identifier: 00840487100295
• UDI-Public: 00840487100295
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 07/23/2023
• Device Model Number: 50-10017
• Device Catalogue Number: 50-10017
• Device Lot Number: AB3600A AND AB3560A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2021
• 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