MAUDE Adverse Event Report: Epocal Inc. epoc Blood Analysis System; epoc Reader

Catalog Number	10736398
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported discrepant low creatinine when compared repeat testing of different samples on a comparative instrument and epoc.There is no report of injury due to this event.
Additional Manufacturer Narrative
The information provided by the customer was reviewed for the escalation.The cause of the event is unknown based on the available information.The customer was unable to provide the requested instrument files for investigation into the raw response of the test in question.Therefore, based on the information provided, there was no evidence to suggest abnormal instrument performance.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.; 855 brookfield road; ottawa, ontario K1V 2 S5; CA K1V 2S5
• Manufacturer Contact: felix akinrinola ; 333 coney street; walpole, MA 02032
• MDR Report Key: 50752796
• Report Number: 3002637618-2026-00109
• Device Sequence Number: 18481988
• Product Code: CHL
• UDI-Device Identifier: 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: 08/18/2026
• Initial Report FDA Received Date: 09/14/2026
• 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: 84 YR
• Patient Sex: Male