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

Model Number	50-10017
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1650733-2021-00020
• Device Sequence Number: 20271071
• Product Code: PGI
• UDI-Device Identifier: 00840487100295
• UDI-Public: 00840487100295
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown