MAUDE Adverse Event Report: GENMARK DIAGNOSTICS, INC. EPLEX® RESPIRATORY PATHOGEN (RP) PANEL; RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM

Catalog Number	09554998001
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument's serial number is (b)(6).The issue was consistent with a lower than intended target concentration within the sample volume analyzed by the assay.This lot contains a raw material that has been identified as having potential for leaks.No leaks were observed, however small amounts of reagent may not be visible.This issue could not be excluded by the investigation.The issue is also consistent with low virus titers that can result in the detection of the influenza a subtype without the influenza a matrix, detection of the influenza a subtype without the influenza a matrix that can also indicate the presence of a novel strain, and for the influenza a matrix and subtype, there is the possibility of false negative values due to the presence of sequence variants in the viral targets of the test.The investigation did not identify a specific cause of the event.
Event or Problem Description
There was an allegation of questionable results using the eplex® respiratory pathogen (rp) panel for 1 patient sample on an eplex system.The patient sample was tested 3 times.It was reported that influenza a h3 was detected during the first test, and there was no signal found for the influenza a target.It was reported that for the second and third tests, no influenza targets were detected either time and no signal was identified in the data.

• Brand Name: EPLEX® RESPIRATORY PATHOGEN (RP) PANEL
• Common Device Name: RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM
• Manufacturer (Section D): GENMARK DIAGNOSTICS, INC.; 5964 la place ct, suite 100; carlsbad CA 92008
• Manufacturer (Section G): GENMARK DIAGNOSTICS, INC.; 5964 la place ct, suite 100; carlsbad CA 92008
• Manufacturer Contact: alan maderazo ; 5964 la place ct, suite 100; carlsbad, CA 92008
• MDR Report Key: 21707932
• Report Number: 3008632402-2025-00909
• Device Sequence Number: 15940787
• Product Code: OCC
• UDI-Device Identifier: 00857167005030
• UDI-Public: 00857167005030
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K163636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/27/2025
• Device Catalogue Number: 09554998001
• Device Lot Number: 10236118
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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