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

Catalog Number	10736398
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Death
Additional Manufacturer Narrative
This report is being filed in an abundance of caution as the customer mentioned a patient death when requesting a review of instrument performance to aid in their morbidity and mortality review case.The customer has stated that no patient treatment was provided based on the results obtained from the epoc instrument.The customer is not alleging that epoc caused or contributed to the death of the patient.No further investigation to be conducted as the customer is unable to provide the requested data.No product problem found.
Event or Problem Description
The customer requested a review of instrument performance to aid in their morbidity and mortality review case.The customer is not alleging that the epoc instrument caused or contributed to the patient death.The customer stated no clinical decisions were made with the results obtained from the epoc.The physician had a result from a different instrument within 10 minutes and their decisions were based on that analysis.Results, patient demographics, date of event, device serial number, and details surrounding the event are unknown.

• 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: 23497462
• Report Number: 3002637618-2025-00076
• Device Sequence Number: 21076083
• Product Code: CHL
• UDI-Device Identifier: 00809708016685
• UDI-Public: (01)00809708016685
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 10736398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown