MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ALINITY M RESP-4-PLEX AMPLIFICATION REAGENT KIT; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Model Number	09N78-095
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident is being reported to fda because the incident occurred internationally using the alinity m resp-4-plex assay, list number 9n79-90, which is the same/ similar to the alinity m resp-4-plex assay, list number 9n79-96, which received fda eua approval.Investigation into this complaint included a customer data review, customer file review, quality data review, and a complaint history review.The results of the investigation are summarized as follows: customer data review: the review of the customer data demonstrated the alinity m resp-4-plex amp kit (list 09n79-090) lot# 382959 and 382437 are performing as expected.There is no indication that lot# 382959 or 382437 is performing outside of established design performance specifications.While the runs were valid and met assay specification requirements, sigmoidal curve are expected to generate a positive result.False negative discrepant patient results identified in this complaint exhibited sigmoidal curve.Sigmoidal curves are not expected to produce negative results.Furthermore, the customer also stated that samples were ran on magpix from luminex, different platforms have different sensitivity therefore the results may not be reproducible between varying testing platforms.A product deficiency was not identified by this evaluation.Quality data review: device history record / batch record review.Review of the manufacturing packet for alinity m resp-4-plex amp kit (list 09n79-090) lot# 382959 (including the components) did not identify any issues which could result in the reported complaint.No issues were found during quality control (qc) testing.The qc amp kit masterlot testing met all acceptance and validity specification criteria.Review of the manufacturing packet for alinity m resp-4-plex amp kit (list 09n79-090) lot# 382437 (including the components) did not identify any issues which could result in the reported complaint.No issues were found during quality control (qc) capa / non-conformance review: a capa review was performed to identify any records that were potentially related to the reported complaint for alinity m resp-4-plex kit (list 09n79-090) lots 382959 and 382437, as well as their components.This capa review did not identify any existing internal issues or nonconformances related to the reported complaint for lots 382959 or 382437, nor their component lots.Complaint history review: the complaint history review identified no additional complaints related to discrepant results for the alinity m resp-4-plex amp kit (part 09n79-090) lots 382959 or 382437 a product deficiency was not identified by this evaluation.Based on the investigation elements, a product deficiency could not be identified by this review.
Event or Problem Description
The customer reported an additional false negative result that occurred on (b)(6) 2022 for sample id (sid) (b)(6) on alinity m resp-4-plex assay lot number 382437.There was no report of impact to patient management.This event is being reported with the following mdr: 3005248192-2022-01248.

• Brand Name: ALINITY M RESP-4-PLEX AMPLIFICATION REAGENT KIT
• Common Device Name: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer Contact: albert chianello ; 1300 e. touhy ave.; des plaines, IL 60018-3315
• MDR Report Key: 16274580
• Report Number: 3005248192-2023-00094
• Device Sequence Number: 12270419
• Product Code: QJR
• UDI-Device Identifier: 00884999049222
• UDI-Public: 00884999049222
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2023

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: 11/01/2023
• Device Model Number: 09N78-095
• Device Catalogue Number: 09N79-90
• Device Lot Number: 382437
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown