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

Catalog Number	10736398
Medical Device Problem Codes	High Test Results (2457); Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/06/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Siemens has requested more information and instrument files for further investigation.Investigation will commence once information has been received.The customer has not alleged that the discrepant result caused or contributed to the patient death.However, siemens is filing this report in an abundance of caution due to the passing of the patient.The cause of this event is unknown.
Event or Problem Description
The customer reported that they received a discrepant high hco3 result of 12.8 on a since deceased patient that did not match clinical picture of the patient.The customer does not know if the patient was treated on the discrepant result.Repeated testing of a new sample gave a result of -17.3.The customer has not provided what their expected result was for this patient.
Additional Manufacturer Narrative
Investigation was completed.The information provided by the customer was reviewed.Raw data files were not provided by the customer for further analysis, however a review of the card lot performance was conducted.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 systemic pattern associated with a specific cause was observed.The cause of the customer¿s issue remains indeterminate.No systemic product problem identified.
Event or Problem Description
Update august 2025: the customer reported discrepant high and low hco3 (calculated from ph and pco2) on a since deceased patient that did not match clinical picture of the patient.The expected values corresponded with the reference ranges.The patient came in for pulseless electrical activity arrest.There are no allegations of unnecessary treatment or procedures being performed, no delayed necessary treatments, and no harm being caused related to the device.

• 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: 22544188
• Report Number: 3002637618-2025-00055
• Device Sequence Number: 20583087
• Product Code: CHL
• UDI-Device Identifier: 00809708016685
• UDI-Public: (01)00809708016685
• 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): 08/28/2025

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?: Yes
• 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: 08/01/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 08/28/2025
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 55 YR
• Patient Sex: Unknown