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	01/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The gm eplex base serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of a false negative staphylococcus aureus result from a positive blood culture using the gm eplex base analyzer.The eplex showed a strong signal for the staphylococcus target.The staphylococcus aureus target result was below the threshold of the assay.The positive result for staphylococcus aureus was confirmed using cultures and mass spectrometry.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The inherent nature of microbes can sometimes lead to false negative results in assays designed to detect them.This could be due to factors such as dormancy, mutations, or the presence of inhibitory substances.Variations within the test target itself can sometimes cause challenges with amplification and the subsequent generation of an electrochemical signal.Bioinformatics analysis confirms the particular strain of staphylococcus aureus recovered would have a low probability of detection due to several mismatches within the primer and probe sequences.

• 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: alan maderazo ; 5964 la place ct, suite 100; carlsbad, CA 92008
• MDR Report Key: 21421372
• Report Number: 3008632402-2025-00497
• Device Sequence Number: 7855018
• Product Code: PAM
• UDI-Device Identifier: 00857167005320
• UDI-Public: 00857167005320
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/01/2025

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: 11/09/2025
• Device Catalogue Number: 09556508001
• Device Lot Number: 10220975
• 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: 01/28/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 05/01/2025
• 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