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	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The gm eplex base analyzer serial number was (b)(6).The investigation did not identify a specific cause of the event.The event was consistent with a lower than intended target concentration within the sample volume analyzed by the assay.Such issues include pipetting errors during sample preparation.Inaccurate pipetting could lead to a lower concentration of the target being transferred to the assay also possible are issues with sample heterogeneity where the target is not evenly distributed within the sample, the portion used for the assay may not accurately represent the overall concentration.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.This could lead to an underestimation of the target concentration.This lot contains a raw material that has been identified as having potential for leaks.No leaks were observed, however small amounts of reagent may not be visible.This issue could not be excluded by the investigation.
Event or Problem Description
There was an allegation of a false negative enterococcus faecalis result from the eplex blood culture identification panel - gram positive (bcid-gp) panel on a gm eplex base analyzer.The initial testing detected only enterococcus.The culture result was enterococcus faecalis.The maldi-tof result was 99%.

• 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: 21900813
• Report Number: 3008632402-2025-01270
• Device Sequence Number: 21010855
• Product Code: PAM
• UDI-Device Identifier: 00857167005320
• UDI-Public: 00857167005320
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Report Date (Section B): 04/24/2025

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: 04/07/2026
• Device Catalogue Number: 09556508001
• Device Lot Number: 10238112
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 04/24/2025
• 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