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); False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas eplex core unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable results for the eplex blood culture identification fungal pathogen (bcid-fp) panel using the cobas eplex core unit.Sample 1 initial result was c.Albicans and c.Famata.On (b)(6) 2025, the repeat result was c.Albicans and c.Famata.The culture results were c.Albicans and c.Dubliniensis sample 2 initial result was c.Dubliniensis and c.Famata.On (b)(6) 2025, the repeat result was c.Famata.The culture result was c.Dubliniensis.
Additional Manufacturer Narrative
The investigation did not identify a specific root cause.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22586086
• Report Number: 3008632402-2025-02245
• Device Sequence Number: 15773610
• Product Code: PEO
• UDI-Device Identifier: 00857167005290
• UDI-Public: 00857167005290
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/18/2025

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: 01/29/2026
• Device Catalogue Number: 09556516001
• Device Lot Number: 10223348
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/18/2025
• 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