MAUDE Adverse Event Report: EPOCAL INC. EPOC HOST

Catalog Number	10736387
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	Sudden Cardiac Death (2510)
Date of Event	07/02/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The customer stated that repeat testing was performed to confirm correct results and a corrected report was issued.Also stated was that the initial sample collected by the paramedics and run on the epoc matched the non-siemens lab analyzer results.Siemens requested t-files or any data files to be extracted from the instrument for investigation.None have been received to date.Until they have been received, only the performance specifications of the lot prior to manufacturing release have being requested.The cause of this event is unknown.
Event or Problem Description
The customer reported discrepant sodium and potassium results on one patient run on the epoc system twice and then compared to a non-siemens lab analyzer.The patient was transported to the hospital due to cardiac arrest.The patient had a history of electrolyte abnormalities.The patient later passed away on the same day, (b)(6) 2020.The customer stated they are not alleging that the epoc device attributed to the patient's demise.
Additional Manufacturer Narrative
Siemens has requested instrument logs from the customer, however the customer has not provided the requested data.The cause of the multiple discrepancies could not be determined from the information provided by the customer.A review of the in-house performance for the card lot used, lot: 10-20082-20, did not identify any product deficiencies.The failure rate of lot: 10-20082-20 is not showing an increased trend in the field, therefore there is no further evidence that the system or reagent cards are not performing as intended.It should be noted that sample contamination, iv line contamination, or sample handling error can all contribute to multiple result discrepancies.The cause of this event is unknown.

• Brand Name: EPOC HOST
• Common Device Name: EPOC
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• MDR Report Key: 10315960
• Report Number: 3002637618-2020-00038
• Device Sequence Number: 16949456
• Product Code: CGL
• UDI-Device Identifier: 00809708052898
• UDI-Public: 00809708052898
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2020

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: 10736387
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/12/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1