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	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The eplex base analyzer serial number was (b)(6).The customer's materials and the patient samples were requested for investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of false negative staphylococcus aureus results for three patient samples using the eplex blood culture identification panel - gram positive (bcid-gp) panel on the eplex base analyzer.Sample 1: on (b)(6) 2025, result was staphylococcus.On (b)(6) 2025, the repeat result was staphylococcus and staphylococcus aureus.The culture result was staphylococcus aureus (mssa).Sample 2: on (b)(6) 2025, result was staphylococcus, enterococcus, and enterococcus faecalis.On (b)(6) 2025, the repeat result was staphylococcus, enterococcus, and enterococcus faecalis.The culture result was staphylococcus aureus (mssa) and enterococcus faecalis.Sample 3: on (b)(6) 2025, result was staphylococcus and pan gram-negative.The culture result was staphylococcus aureus (mssa), e.Coli, and k.Pneumoniae.
Additional Manufacturer Narrative
The customer returned consumables from the implicated lot along with the aliquots from samples 1 and 2 for internal testing.Each blood aliquot was run in duplicate, on the returned material and the customer allegations were not reproducible.An internal review of qc release data for the affected lot confirms the consumable lot met the established qc release specifications.The investigation determined the issue was consistent with a lower than intended target concentration within the sample volume analyzed by the assay.It is possible that a low target concentration was withdrawn and loaded for analysis.This can create a limit of detection challenge if the concentration is at or near the analytical sensitivity of the assay.With samples 1 and 2, the polymicrobial nature of the samples could contribute the unexpected results.In mixed cultures, the cobas eplex bcid-gp panel may not identify all organisms in the specimen, depending upon the concentration of each target present.Based on the available data and analysis, no product quality issue was suspected.No run malfunction was observed with the eplex instrument.

• 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: 21651368
• Report Number: 3008632402-2025-00784
• Device Sequence Number: 18519439
• Product Code: PAM
• UDI-Device Identifier: 00857167005320
• UDI-Public: 00857167005320
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/21/2025

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: 11/14/2025
• Device Catalogue Number: 09556508001
• Device Lot Number: 10220977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 03/21/2025
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 83 KG