MAUDE Adverse Event Report: GENMARK DIAGNOSTICS, INC. EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE (BCID-GN) PANEL; GRAM-NEGATIVE BACTERIA AND ASSOCIATED RESISTANCE MARKERS

Catalog Number	09556494001
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable results using the eplex blood culture identification gram negative (bcid-gn) panel for 1 patient on an eplex system.The sample was reported as reactive for both escherichia coli and the ndm resistance gene.Subsequent susceptibility testing on 30-mar-2025 did not correlate with the eplex result.On 30-mar-2025, the sample was retested four times, and escherichia coli was detected, but the ndm resistance gene was not detected.The culture and susceptibility tests matched the repeated eplex results that indicated the absence of the ndm resistance gene.
Additional Manufacturer Narrative
The eplex base analyzer serial number was (b)(6).No analyzer malfunction was observed, and the eplex instrument was working within design specifications.An internal review of qc release data for the affected consumable lot confirmed that the consumable lot successfully met the established qc release specifications.The sample was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
Sample material from the patient was received for further investigation.The received sample was lysed due to age.The blood culture sample was tested in duplicate on the same lot of the bcid-gn panel, which resulted in the detection of only the escherichia coli target.The sample was cultured, and a single colony was observed.Multiple colony suspensions were made and tested on the bcid-gn assay, which detected escherichia coli only.The sample was then replated and recultured.No colonies were observed.Gdna wgs sequencing was performed from the whole blood (lysed) patient sample, and an uncommon mutation was found in the uida gene throughout its sequence.The reverse primer binding site for the assay amplicon region demonstrated a rare, yet unremarkable, mismatch at the 6th base from 5¿ end.Blast results were unable to find an exact match to the reverse primer binding site sequence, suggesting a novel strain or an unlikely consistent sequencing error.Per the bcid-gn assay package insert: "the antimicrobial resistance gene detected may or may not be associated with the agent responsible for the disease".The investigation was unable to determine the specific root cause of the event; however, the issue appears to be sample-specific.Based on internal testing, current available data, and provided information, no product quality issue was suspected.

• Brand Name: EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE (BCID-GN) PANEL
• Common Device Name: GRAM-NEGATIVE BACTERIA AND ASSOCIATED 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: 21892560
• Report Number: 3008632402-2025-01246
• Device Sequence Number: 8190225
• Product Code: PEN
• UDI-Device Identifier: 00857167005313
• UDI-Public: 00857167005313
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K182619
• 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): 07/11/2025

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: 01/11/2026
• Device Catalogue Number: 09556494001
• Device Lot Number: 10243821
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 07/11/2025
• 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: 17 YR
• Patient Sex: Female