MAUDE Adverse Event Report: EPOCAL INC. EPOC READER, HOST

Model Number	11413524
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has requested instrument files for further investigation; however, the customer did not provide them.The in-house performance of sodium for the card lot in question was reviewed, did not identify any product deficiencies.Aqueous fluids and arterialized blood performed as expected and met product specifications at the time of release.Card lot was also tested throughout lifetime with whole blood against comparative instruments and performed as expected.Therefore, there is no evidence that the system or reagent cards are not performing as intended.It should be noted that epoc and competitor device use two different measurement methods, direct vs indirect, respectively.Per the manual, "the epoc sodium measurement is an undiluted (direct) method.Values may differ from those obtained by dilutional (indirect) methods." differences in instrument methodologies cannot be ruled out as a root cause of the alleged na discrepancies at the customer site.There was no harm, or delay in patient reporting impacting medication, procedure, treatment or interventions for a patient and/or to protect public health.The cause of this event is unknown.
Event or Problem Description
The customer reported that their epoc instrument gave a discrepant high sodium result compared to retesting of the same sample on a non-siemens instrument.There is no report of injury due to this event.

• Brand Name: EPOC READER, HOST
• Common Device Name: EPOC
• 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: thomas myers ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 15729710
• Report Number: 3002637618-2022-00068
• Device Sequence Number: 2919598
• Product Code: CGL
• UDI-Device Identifier: 00630414606460
• UDI-Public: 00630414606460
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113726
• 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): 11/03/2022

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 Model Number: 11413524
• Device Catalogue Number: 11413524
• Device Lot Number: 11-22218-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 11/04/2022
• 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: 1 YR
• Patient Sex: Unknown