MAUDE Adverse Event Report: GENMARK DIAGNOSTICS, INC. EPLEX BLOOD CULTURE IDENTIFICATION FUNGAL PATHOGEN (BCID-FP) PANEL; FUNGAL ORGANISMS, NUCLEIC ACID-BASED ASSAY

Catalog Number	09556516001
Medical Device Problem Codes	False Negative Result (1225); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable results for two patient samples using the eplex blood culture identification fungal pathogen (bcid-fp) panel on a eplex instrument.Sample 1 initially generated negative results, however, maldi identification of the subculture growth was candida lusitaniae with log score >2.On (b)(6) 2024, sample 2 initially generated a positive result for the candida parapsilosis target.Culture detected candida parapsilosis and candida lusitaniae.The maldi log score was >2.
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(6).Investigation is ongoing.
Additional Manufacturer Narrative
It was reported that the alleged two samples were from the same patient.The samples were two aliquots from two different blood culture bottles.The investigation consisted of analyzing the dataset provided by the customer, reviewing internal documentation as well as testing customer returned materials.A review of the data did not show any abnormalities.Additionally, no run malfunction was observed and the eplex instrument was working within design specifications.An internal review showed that the complaint lot met established qc release specifications and was released successfully.The internal testing from blood culture on both aliquots resulted in the presence of candida lusitaniae and candida parapsilosis.Based on the information and data provided and the investigation performed, there is no indication of a product problem.The issue is sample-specific.In mixed cultures, cobas® eplex bcid-fp assay test panel may not identify all organisms in the specimen, depending upon the concentration of each target present.A review of the provided data indicated that the alleged sample is at the limit of detection of the assay.The target concentration was likely at or near the analytical sensitivity of the assay, resulting in no target detected.Additionally, per the method sheet, "there is a risk of false negative results due to the presence of sequence variants in the fungal targets of the test.".

• Brand Name: EPLEX BLOOD CULTURE IDENTIFICATION FUNGAL PATHOGEN (BCID-FP) PANEL
• Common Device Name: FUNGAL ORGANISMS, NUCLEIC ACID-BASED ASSAY
• 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: 20783765
• Report Number: 3008632402-2024-03436
• Device Sequence Number: 8942843
• Product Code: PEO
• UDI-Device Identifier: 00857167005290
• UDI-Public: 00857167005290
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K182690
• 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,Followup
• Report Date (Section B): 12/26/2024

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: 10/09/2025
• Device Catalogue Number: 09556516001
• Device Lot Number: 10210467,10207754
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/26/2024
• 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 Age: 35 MO
• Patient Sex: Male