MAUDE Adverse Event Report: EPOCAL INC. EPOC READER

Model Number	HR-1R02-00-00
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that their epoc instrument gave a discrepant low sodium result compared to retesting of the same sample on a non-siemens instrument.There is no report of injury due to this event.
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.Aqueous fluids and arterialized blood performed as expected and met product specifications at the time of release.Additional testing was performed with blood representative of the customer testing range.All epoc test results were centered within the allowable total error and comparable to test results provided by other blood gas analyzers.Differences in instrument methodologies cannot be ruled out as a root cause of the alleged sodium discrepancy(ies) at the customer site.Therefore, there is no evidence that the system or reagent cards are not performing as intended the cause of this event is unknown.

• Brand Name: EPOC READER
• 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: tim krauskopf ; 2 edgewater drive; norwood, MA 02062 ; 6107052212
• MDR Report Key: 15007170
• Report Number: 3002637618-2022-00040
• Device Sequence Number: 19425225
• Product Code: CGL
• UDI-Device Identifier: 00809708032333
• UDI-Public: 00809708032333
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 07/13/2022

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: HR-1R02-00-00
• Device Catalogue Number: 10736401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 07/13/2022
• 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: 29 YR
• Patient Sex: Male