MAUDE Adverse Event Report: GENMARK DIAGNOSTICS, INC. EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE (BCID-GN) PANEL; GRAM-NEGATIVE BACTERIA AND ASSOCIATED RESISTANCE MARKERS

Catalog Number	09556494001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged that there was a sample leak within the cobas eplex analyzer after running the cobas eplex blood culture identification gram negative (bcid-gn) panel.The customer reported that an alleged positive sample for neisseria meningitidis was leaked within a bay of the analyzer.
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).Roche personnel deinstalled and decontaminated the instrument.He replaced the affected bay and reinstalled the instrument and confirmed its operation by running negative media runs as well as a positive control sample and obtained valid and expected results.The investigation is ongoing.
Additional Manufacturer Narrative
Post-run images of the affected bcid-gn consumable revealed a patient sample leak from atop the shroud and beneath the sample cap.These leaks are often due to sample cap defects, specifically damaged or out-of-spec gaskets from a mold defect, which compromise the seal.The investigation determined that this incident is likely a rare and isolated event.Replacement materials have been provided to the customer to facilitate the resolution of the issue.In addition, an improved mold maintenance procedure was implemented at the manufacturer.The instrument can continue to be used for sample testing.

• Brand Name: EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE (BCID-GN) PANEL
• Common Device Name: GRAM-NEGATIVE BACTERIA AND ASSOCIATED RESISTANCE MARKERS
• 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: 22685465
• Report Number: 3008632402-2025-02367
• Device Sequence Number: 8844373
• Product Code: PEN
• UDI-Device Identifier: 00857167005313
• UDI-Public: 00857167005313
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K182619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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: 02/09/2026
• Device Catalogue Number: 09556494001
• Device Lot Number: 10235377
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 11/14/2025
• 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