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	02/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The eplex base unit serial numbers were (b)(6).Sampler material from the patient was requested for further investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of false negative staphylococcus aureus results for two samples from the same patient using the eplex blood culture identification panel - gram positive (bcid-gp) panel results with the eplex base units.The samples were from the same patient but different bottle sets.The tests were performed on (b)(6) 2025.Sample 1 was tested on analyzer eplex serial number (b)(6) multiple times and then tested on eplex serial number (b)(6).Sample 2 was only tested on eplex serial number (b)(6).All of the results from the eplex analyzers were staphylococcus species.The culture results were staphylococcus aureus (mssa).
Additional Manufacturer Narrative
The investigation did not identify a product problem.The event was consistent with sample-related factors, such as a lower than intended target concentration within the sample volume analyzed by the assay, or with variations within the intended test target.There is a risk of false-negative results due to the innate nature of microbes.
Additional Manufacturer Narrative
Medwatch field d4 lot no was updated.The two patient samples were received for further investigation.Both samples were tested, and staphylococcus and staphylococcus aureus were detected.The investigation did not identify a product problem.The cause of the event could not be determined, but the event was consistent with sample-related issues.It was possible that a lower than intended target concentration was within the sample volume analyzed by the assay.

• 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: 21662205
• Report Number: 3008632402-2025-00814
• Device Sequence Number: 8737758
• Product Code: PAM
• UDI-Device Identifier: 00857167005320
• UDI-Public: 00857167005320
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 05/07/2025

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: 11/30/2025
• Device Catalogue Number: 09556508001
• Device Lot Number: 10240086
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 05/02/2025; 04/16/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 05/05/2025; 05/07/2025
• 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