MAUDE Adverse Event Report: EPOCAL INC. EPOC BLOOD ANALYSIS SYSTEM; EPOC READER

Catalog Number	10736398
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported discrepant a pco2 result on a patient when compared to repeat testing of different samples on the same instrument.The customer noted that there was a possible contamination with total parenteral nutrition to the draw site for the discrepant result.There is no report of injury due to this event.
Additional Manufacturer Narrative
Instrument files and information have been provided by the customer.Investigation ongoing.The cause of this event is unknown.
Additional Manufacturer Narrative
The reported issue of high and variable pco2 readings was reviewed in detail.The samples used for measurement were venous blood.Venous samples are inherently subject to physiological variability due to differences in local tissue perfusion, metabolic activity, and sampling techniques.These factors can lead to fluctuations in pco2 levels that are not necessarily indicative of test card performance.Additionally, the pco2 value from the samples which provide believable results closely resemble the sample the customer previously deemed unreliable/contaminated.Given that venous blood is known for its perfusion-dependent variability, this resemblance may be coincidental and not indicative of a systemic issue.Therefore, it is likely that the use of venous blood, known for its variability in pco2 may have contributed to the perceived inconsistency in results.This, combined with uncertainty around the discrepant sample, suggests that the observed discrepancies may stem from sample-related factors rather than instrument or card lot specific issue.Review of customer-provided data, pre-analytical factors, and interferents does not identify other causes for the issue.Review of in-house data for the card lot under investigation is unable to confirm the customer¿s observed issue.Review of internal records do not identify any other production issues, deviations, or other escalations that would cause the customer¿s reported issue.No product problem identified.

• Brand Name: EPOC BLOOD ANALYSIS SYSTEM
• Common Device Name: EPOC READER
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• Manufacturer (Section G): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• Manufacturer Contact: felix akinrinola ; 333 coney street; walpole, MA 02032
• MDR Report Key: 23094457
• Report Number: 3002637618-2025-00070
• Device Sequence Number: 9226228
• Product Code: CHL
• UDI-Device Identifier: 00809708016685
• UDI-Public: (01)00809708016685
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K200107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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 Catalogue Number: 10736398
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/22/2025
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown