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	02/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The eplex base analyzer serial number is (b)(6).The alleged sample was received for investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable results using the eplex blood culture identification panel - gram positive (bcid-gp) panel for 1 patient sample on an eplex system.It was reported that the staphylococcus epidermidis target was detected in culture, but the bcid-gp test result was negative for the staphylococcus epidermidis target.The sample was received for investigation.During the investigation, the bcid-gp test result was negative for the meca and staphylococcus genus targets.
Additional Manufacturer Narrative
No analyzer malfunction was observed, and the eplex instrument was working within design specifications.The returned sample was tested in duplicate on the bcid-gp panel.Both runs identified the staphylococcus genus, staphylococcus epidermidis, and meca targets with robust detection signals.Positive culture results were observed.Based on the internal testing of the returned sample, the customer's allegation was not reproducible during the investigation.The issue was consistent with a lower-than-intended target concentration within the sample volume analyzed by the assay.The issue is also consistent with a low target concentration withdrawn and loaded into the delivery port.Based on the bcid-gp assay pi, the resistance gene is only reported if its associated organism assay is positive in the same sample.Additionally, this lot was found to be related to sample cap failures and/or leaking consumables, which may be detected through invalid results or unexpected negative results.Although a leakage issue was neither alleged nor confirmed during the complaint investigation, this issue could not be excluded by the investigation.Improper sample handling could also not be excluded.The investigation did not identify a specific cause of the event.

• 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: 21777455
• Report Number: 3008632402-2025-01024
• Device Sequence Number: 7696072
• Product Code: PAM
• UDI-Device Identifier: 00857167005320
• UDI-Public: 00857167005320
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 07/23/2025

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: 03/11/2026
• Device Catalogue Number: 09556508001
• Device Lot Number: 10235368
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 07/23/2025
• 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