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	03/23/2025
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.Polymicrobial infections may result in the panel not being able to identify all organisms in the specimen, depending on the concentration of each target present.It is likely that insufficient target concentration resulted in the inability of the gram-positive assay to breach the limit of detection and make a positive call for the discrepant organisms.In mixed cultures, the cobas® eplex bcid-gp assay test panel may not identify all organisms in the specimen, depending upon the concentration of each target present.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.Antimicrobial resistance can occur via multiple mechanisms.A not detected result for the bcid-gp antimicrobial resistance gene assays does not indicate that the bacteria are susceptible to antibiotics.Based on the available data analysis, no product quality issue was suspected.
Event or Problem Description
There was an allegation of false negative staphylococcus and mec a resistance gene results from the eplex blood culture identification panel - gram positive (bcid-gp) panel on a gm eplex base analyzer.The initial testing resulted in the detection of pan gram-negative only.The sample was then retested on the eplex and resulted in the detection of staphylococcus species and pan-gram-negative.The culture for the sample resulted in serratia marcescens, coagulase-negative staphylococcus, and oxacillin resistance.

• 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: 21900774
• Report Number: 3008632402-2025-01269
• Device Sequence Number: 12960630
• Product Code: PAM
• UDI-Device Identifier: 00857167005320
• UDI-Public: 00857167005320
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: 03/02/2026
• Device Catalogue Number: 09556508001
• Device Lot Number: 10235370
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2025
• 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