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	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The eplex base analyzer serial numbers were (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of false negative klebsiella oxytoca results for one patient using the eplex blood culture identification gram negative (bcid-gn) panel on eplex base analyzers.The initial test for the sample using eplex base analyzer serial number: (b)(6) detected only serratia marcescens.On (b)(6) 2025, the sample was repeated two times using eplex base analyzer serial number: (b)(6) and the results were the same.The culture results were serratia marcescens and klebsiella oxytoca.Using maldi-tof testing, klebsiella oxytoca was identified.The organism was not identified during biofire comparator testing.Serratia marcescens was reported out initially.The klebsiella oxytoca result was not reported until after the culture result was confirmed.
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 there is a risk of false-negative results due to the innate nature of microbes.

• 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: 21662208
• Report Number: 3008632402-2025-00815
• Device Sequence Number: 12946062
• Product Code: PEN
• UDI-Device Identifier: 00857167005313
• UDI-Public: 00857167005313
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 05/05/2025

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: 12/15/2025
• Device Catalogue Number: 09556494001
• Device Lot Number: 10227733
• 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
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 05/05/2025
• 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