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	03/26/2025
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 issue was consistent with a lower than intended target concentration within the sample volume analyzed by the assay.This could result in a 'not detected' outcome if the gene's concentration was near or below the assay's limit of detection.The unexpected negative result could be due to a variation within the target sequence.There is a risk of false-negative results due to the presence of sequence variants in the bacterial targets of the test.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 false negative staphylococcus and meca resistance gene results while using the eplex blood culture identification panel - gram positive (bcid-gp) panel on a gm eplex base analyzer.The result for the initial test was no targets detected.The culture result for this sample was staphylococcus haemolyticus.On (b)(6) 2025, the sample was retested on the eplex and resulted in the detection of staphylococcus species and meca resistance gene.

• 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: 21942583
• Report Number: 3008632402-2025-01356
• Device Sequence Number: 9122036
• 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
• 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: 03/22/2026
• Device Catalogue Number: 09556508001
• Device Lot Number: 10235363
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2025
• Initial 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