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	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas eplex core unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable false-positive results from the eplex blood culture identification gram negative (bcid-gn) panel on a cobas eplex core unit for a single patient sample.On (b)(6) 2025, initial results were bacteroides fragilis, escherichia coli, pan gram-positive, ctx-m, imp, and oxa detected.The repeat test had escherichia coli detected.
Additional Manufacturer Narrative
The investigation did not indicate that a product problem was identified.The most significant causal factor is the failure of the dsp to perform a correct curve fit.This is not a root cause in itself but rather the result of compounding issues.The problems, whether they stem from the raw materials, the equipment, or a combination of both, are creating data that is too noisy to accurately analyze.This explains why the unusually high background current and/or no signal on certain pads.Raw data analysis showed a consistently high background current.This could be caused by an issue with a manufacturing process affecting a raw material (salting buffer).Another manufacturing process/raw material issue (silver splatter from the reference electrode) remains a possible cause for the pads in zone a with no signal/errors.The data shows that the most severe errors (runs with more than two pad errors) are concentrated exclusively at the cmc site.This strongly suggests a site-specific contributing factors, such as a leveling or alignment limitations, could be a contributing factor.A physical misalignment could help create the noisy data that the dsp is failing to process.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 23095893
• Report Number: 3008632402-2025-03182
• Device Sequence Number: 9383416
• Product Code: PEN
• UDI-Device Identifier: 00857167005313
• UDI-Public: 00857167005313
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/17/2025

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: 06/29/2026
• Device Catalogue Number: 09556494001
• Device Lot Number: 10246312
• 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: 08/22/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/17/2025
• 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