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 Codes	False Negative Result (1225); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received false negative results for three patient samples tested with the eplex blood culture identification gram negative (bcid-gn) panel on a cobas eplex core unit.For the first sample, the eplex did not detect any targets, including klebsiella pneumoniae and ctx-m.A concurrent culture of the sample grew esbl klebsiella pneumoniae.For the second sample, the eplex detected escherichia coli.The concurrent culture grew micrococcus luteus.Raw data analysis confirmed that the pan gram positive target was not detected.The third sample was tested on (b)(6) 2025 and the eplex did not detect any targets.The concurrent culture grew acinetobacter baumannii complex.Raw data analysis confirmed that the acinetobacter baumannii complex target was not detected.
Additional Manufacturer Narrative
The serial number of the cobas eplex core unit is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
An internal review of qc release data for the affected lot confirms that the consumable lot met the established qc release specifications.For the first sample, investigations have determined that it is likely the sample volume analyzed by the assay contained a lower concentration of the target than intended.If the target concentration is close to or below the assay¿s sensitivity, it may be difficult to accurately detect the target.For the second sample, micrococcus luteus is an off-panel organism and per product labeling, does not have predicted inclusivity at the pan-gp target.For the third sample, investigations have determined that it is likely the sample volume analyzed by the assay contained a lower concentration of the target than intended.If the target concentration is close to or below the assay¿s sensitivity, it may be difficult to accurately detect the target.The exact strain identified contains variations within the assay target sequences, which can compound limit of detection challenges.Investigations have determined the affected product is performing within expected standards.The released product is fit for intended use and meets all quality and performance requirements.

• 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: 24167764
• Report Number: 3008632402-2026-00261
• Device Sequence Number: 15850479
• Product Code: PEN
• UDI-Device Identifier: 00857167005313
• UDI-Public: 00857167005313
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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 Catalogue Number: 09556494001
• Device Lot Number: 10270192
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 02/16/2026
• 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