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 Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable results using the cobas® eplex blood culture identification gram negative panel for one patient sample on a cobas eplex system.The alleged sample initially generated a negative result for all targets.On (b)(6) 2024, the same sample was used for the repeat testing which resulted in a negative result for all targets.The customer reported that escherichia coli was detected in culture.
Additional Manufacturer Narrative
The serial number of the cobas eplex instrument is (b)(4).Investigation is ongoing.
Additional Manufacturer Narrative
The investigation consisted of analyzing the dataset provided by the customer, reviewing internal documentation as well as testing of customer returned material.A review of the data did not show any abnormalities.Additionally, no run malfunction was observed and the eplex instrument was working within design specifications.An internal review showed that the complaint lot met established qc release specifications and was released successfully.A global trend was not met for the complaint lot as this is the first allegation of a false result discrepancy.The original blood culture bottle was not available for testing.However, the customer provided a slant tube containing the organism.The slant tube was cultured on bap, cna, and macconkey agar, which resulted in few colonies.Colonies were collected and the colony suspension was tested in duplicate using the bcid-gn panel using the same complaint lot.The internal testing of the returned material from 16s sequence results showed hits for escherichia coli and shigella.The sequence similarities between the two organisms were too high to confirm if the sequence was truly escherichia coli.Based on the information and data provided and the investigation performed, there is no indication of a product problem.It is likely that the unexpected negative could be due to a variation within the target sequence.Per the procedural notes of the method sheet, "there is a risk of false negative results due to the presence of sequence variants in the bacterial targets of the test." additionally, since the original blood culture bottle was not provided, using the slant tube may hinder determining the exact root cause.

• 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: 20344044
• Report Number: 3008632402-2024-02827
• Device Sequence Number: 15467582
• Product Code: PEN
• UDI-Device Identifier: 00857167005313
• UDI-Public: 00857167005313
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• 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): 11/22/2024

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: 06/16/2025
• Device Catalogue Number: 09556494001
• Device Lot Number: 10200973
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/22/2024
• 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: 77 YR
• Patient Sex: Male