MAUDE Adverse Event Report: LUMINEX CORPORATION ARIES SARS-COV-2 EUA

Catalog Number 50-10047

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 10/10/2022

Event Type  malfunction  

Manufacturer Narrative

In review of all case details against the criteria set forth in document: (b)(4) (medical device reporting standard operating procedure) and its applicable appendices, this complaint does meet the requirements for an mdr.The mdr is being submitted to us fda pursuant to the obligations of the emergency use authorization, and per communication received from fda on october 7, 2020.

Event Description

The customer is reporting a false negative while utilizing the sars-cov-2 assay on their api survey.The customer confirmed the lot passed with qc, and the api survey was successful with a different lot number.Data review: on (b)(6) 2022 customer (b)(6) hospital contacted luminex technical support to report a false negative result for aries sars-cov2-eua assay pn: 50-10047.The reported false negative occurred while running an api covid positive sample on lot: ab6640a.Customer provided the assay run file which confirms there was no detection of either then target or the orf1ab target for the sample (sample id: (b)(6) run using the api provided cov-05 sample.Consumable review: no false negative results were reported during qc testing of lot: ab6640a on 06/20/2022.There is one ncmr associated with this lot, however, the ncmr was for a documentation error (reference:(b)(4).There is one additional complaint case for lot: ab6640a related to a false negative result reported in salesforce at this time.Lot: ab6640a is being recalled in rc-22-016 for a potential product defect that could lead to false negative results.Device review: aries system sn: (b)(4).Review of the utilized device's history was accessed for a period of 6 months prior to the reported discrepant result with no findings of false negative result complaints for this system.There were no service actions for the aries system during the prior 6 months that would contribute to false results.Sample work-up: sample tested was identified as cov-05 by api.Api confirmed the concentration of their sample cov-05 to be approximately 1360 copies/ml for sars-cov-2.Conclusion: the root cause of the false negative api sample results cannot be determined.There is no indication of a hardware malfunction or evidence of consumable malfunction at this time.No patient samples were reported to have discrepant results.

• Brand Name: ARIES SARS-COV-2 EUA
• Type of Device: ARIES SARS-COV-2 EUA
• Manufacturer (Section D): LUMINEX CORPORATION; 12212 technology blvd; austin TX 78727
• Manufacturer Contact: jennifer svoboda ; 12212 technology blvd; austin, TX 78727
• MDR Report Key: 16000792
• MDR Text Key: 308260310
• Report Number: 1650733-2022-00060
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/16/2022

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: 06/08/2023
• Device Catalogue Number: 50-10047
• Device Lot Number: AB6640A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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