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 Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of discrepant results for three patient samples using the cobas® eplex blood culture identification fungal pathogen (bcid-gp) panel on a eplex base.The alleged samples generated negative results for candida auris.The culture results identified candida auris.
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(6).The investigation is ongoing.

• 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: 24056811
• Report Number: 3008632402-2026-00163
• Device Sequence Number: 18497047
• Product Code: PEO
• UDI-Device Identifier: 00857167005290
• UDI-Public: 00857167005290
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/01/2026

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: 07/02/2026
• Device Catalogue Number: 09556516001
• Device Lot Number: 10235373
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 05/01/2026
• 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