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

Catalog Number	10736404
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported discrepant high potassium when compared to repeat testing of the same sample on a laboratory instrument.There is no report of injury due to this event.
Additional Manufacturer Narrative
Siemens has requested the necessary information and data files.Investigation will commence once they are received.The cause of this event is unknown.
Additional Manufacturer Narrative
The customer was unable to provide the additional information and instrument for investigation.Without the requested information, the investigation cannot proceed and therefore the root cause cannot be determined.However, a review of the certificate of analysis was performed on the lot in use at the time of the event.The lot was performing as intended at time of product release.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: 22713915
• Report Number: 3002637618-2025-00060
• Device Sequence Number: 9583422
• Product Code: CHL
• UDI-Device Identifier: 00809708116712
• UDI-Public: (01)00809708116712
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/26/2025

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: 10736404
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 09/26/2025
• 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
• Patient Age: 5 DA
• Patient Sex: Unknown