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	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer provided instrument files.Investigation ongoing.
Event or Problem Description
The customer reported discrepant high ph on one patient when compared to repeat testing on the same instrument.There is no report of injury due to this event.
Additional Manufacturer Narrative
Siemens healthcare diagnostics inc.Has confirmed the occurrence of discrepant high ph results in samples introduced with higher injection volumes (beyond the epoc reader beep or after the "analyzing sample" message is displayed) with epoc sensor configuration 45.N (software version: epoc host v3.41.2 and epoc nxs v4.14.9 & 4.14.11).It should be noted that total carbon dioxide (tco2) is a measured value that uses the ph result and that discrepant high ph results may affect the following calculated values: anion gap (agap) (through chco3 or tco2), base excess (blood) (be(b)), base excess (extra cellular fluid) (be (ecf), calculated bicarbonate (chco3-), calculated oxygen saturation (cso2), calculated total carbon dioxide (ctco2).Siemens healthcare diagnostics determined the root cause of the ph bias to be caused by sensor configuration 45.N.Siemens has released a notification "discrepant high ph results with sensor configuration 45.N" to inform customers of the issue and provide a workaround option.Crr#: 3002637618-03-19-2025-001-c.

• 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: 21434709
• Report Number: 3002637618-2025-00016
• Device Sequence Number: 19984732
• Product Code: CHL
• UDI-Device Identifier: 00809708116712
• UDI-Public: (01)00809708116712
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/26/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3002637618-03-19-2025-00
• Patient Sequence Number: 1
• Patient Sex: Unknown