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

Catalog Number	10736398
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Data and additional information has been requested from the customer.Investigation will commence once they are received.The cause of this event is unknown.
Event or Problem Description
The customer reported discrepant high hemoglobin (and hematocrit) when compared to repeat testing of a new sample on a comparative instrument.There is no report of injury due to this event.
Additional Manufacturer Narrative
The available information provided by the customer was reviewed; no instrument files were available for assessment.Based on the information provided, there was no evidence to suggest abnormal instrument performance.The customer was unable to provide information about medication or other factors that may influence the results.The customer stated that the patient had severe anemia.It should be noted that calculated hemoglobin (chgb) is derived using the formula chgb (g/dl) = hct (decimal fraction) × 34, which assumes a normal mean corpuscular hemoglobin concentration (mchc) of approximately 34%.The customer could not provide information on the patients mchc value from the lab.A patient with severe anemia may have an abnormal mchc value.The certificate of analysis for the test card lot used on the device was reviewed and verified that the lot met all applicable specifications at the time of release.No systemic issues were identified based on the available information.The cause of the event is 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: 24594123
• Report Number: 3002637618-2026-00016
• Device Sequence Number: 10355766
• Product Code: CHL
• UDI-Device Identifier: 00809708016685
• UDI-Public: (01)00809708016685
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K200107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• 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): 04/24/2026

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: 03/03/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/24/2026
• 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 Age: 75 YR
• Patient Sex: Male