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

Model Number 11413524

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 303409140
• Report Number: 3002637618-2022-00068
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00630414606460
• UDI-Public: 00630414606460
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 1 YR