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 Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable results with the eplex blood culture identification panel - gram positive (bcid-gp) panel for 8 patient samples tested on the eplex analyzer.Sample 1: the eplex results were enterococcus, enterococcus faecalis, vana; listeria, listeria monocytogenes, lactobacillusm and pan gram-negative.The culture results were leuconostoc pseudomesenteroides.Sample 2 ((b)(6) 2026): the eplex results were enterococcus, enterococcus faecalis, lactobacillus, staphylococcus, staphylococcus aureus, meca, and vana.The culture results were methicillin resistant staphylococcus aureus.Sample 3 ((b)(6) 2026): the eplex results were enterococcus, enterococcus faecalis, lactobacillus, listeria, listeria monocytogenes, staphylococcus, streptococcus, strep agalactiae, pan gram-negative, meca, and vana.The culture result was staphylococcus hominis.Sample 4 ((b)(6) 2026): the eplex results were enterococcus, enterococcus faecalis, lactobacillus, listeria, listeria monocytogenes, streptococcus, strep agalactiae, pan gram-negative, and vana.The repeat eplex result was streptococcus detected.The culture results were streptococcus halichoeri (identified by a reference lab).Sample 5 ((b)(6) 2026): the eplex results were enterococcus, enterococcus faecalis, listeria, listeria monocytogenes, and pan gram-negative.The repeat eplex result was no targets detected.The culture results were clostridium ramosum, granulicatella adiacens, rothia dentocariosa.Sample 6 ((b)(6) 2026): the eplex results were enterococcus, enterococcus faecalis, lactobacillus, listeria, listeria monocytogenes, staphylococcus, staphylococcus epidermidis, streptococcus, strep agalactiae, and pan gram-negative.The repeat eplex results were staphylococcus and staphylococcus aureus targets.The culture result was staphylococcus epidermidis.Sample 7 ((b)(6) 2026): the eplex results were enterococcus, enterococcus faecalis, listeria monocytogenes, streptococcus agalactiae, pan-gram negative, listeria, lactobacillus targets, staphylococcus, and meca.The repeat eplex results were staphylococcus and meca targets.The culture result was staphylococcus capitis.Sample 8 ((b)(6) 2026): the eplex results were enterococcus, enterococcus faecalis, listeria, listeria monocytogenes, pan gram-negative, staphylococcus aureus and staphylococcus targets, and stenotrophomonas maltophilia.The repeat eplex results were staphylococcus aureus and staphylococcus targets.The culture result was staphylococcus aureus.
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(4).The investigation is ongoing.

• 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: 25142445
• Report Number: 3008632402-2026-01848
• Device Sequence Number: 18493415
• Product Code: PAM
• UDI-Device Identifier: 00857167005320
• UDI-Public: 00857167005320
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/17/2026

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: 10281623
• 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: 04/17/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 07/17/2026
• 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