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	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas eplex core unit serial number was (b)(6).Negative and positive external controls were analyzed, and do not show any unexpected detections at any targets.The investigation did not identify a specific root cause.The issue was consistent with issues that occurred during the manufacturing process, causing nonspecific binding, resulting in background signal overcoming the limit of detection and generating 'detected' results.Based on the analysis, the consumable lot was performing within expected standards, and the observed issue was limited to the specified consumables.
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.Sample 1 initial results were bacteroides fragilis, cronobacter sakazakii, k.Pneumoniae group, stenotrophomonas maltophilia, pan gram positive, imp, and oxa detected.The repeat test on (b)(6) 2025 had k.Pneumoniae group detected.Sample 2, on (b)(6) 2025, initial results were bacteroides fragilis, cronobacter sakazakii, escherichia coli, stenotrophomonas maltophilia, pan gram positive, ctx-m, imp, oxa detected.The repeat test had e.Coli detected.

• 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
• MDR Report Key: 22818970
• Report Number: 3008632402-2025-02523
• Device Sequence Number: 17571241
• 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
• Report Date (Section B): 08/15/2025

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): Initial
• Initial Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 08/15/2025
• 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