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

Catalog Number	09556508001
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of discrepant results for three patient samples using the cobas® eplex blood culture identification gram-positive (bcid-gp) panel on a eplex base.The alleged samples generated a negative result for staphylococcus aureus, vre enterococcus faecium, or staphylococcus lugdunensis.The following culture results were believed to be correct: sample 1: mssa methicillin susceptible staphylococcus aureus.Sample 2: vre enterococcus faecium.Sample 3: staphylococcus lugdunensis.
Additional Manufacturer Narrative
The investigation indicated that no product issue was identified.The issue is consistent with a limit of detection challenge.It is possible that 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.An internal review of qc release data for the affected lot confirms that the consumable lot met the established qc release specifications.Based on the provided analysis, the consumable lot 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 PANEL - GRAM POSITIVE (BCID-GP) PANEL
• Common Device Name: GRAM-POSITIVE BACTERIA AND THEIR 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: 24057126
• Report Number: 3008632402-2026-00164
• Device Sequence Number: 9465855
• Product Code: PAM
• UDI-Device Identifier: 00857167005320
• UDI-Public: 00857167005320
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K181663
• 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): 02/24/2026

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: 09556508001
• Device Lot Number: ASKU
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/24/2026
• 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