MAUDE Adverse Event Report: EPOCAL INC. EPOC HOST

Catalog Number 10736387

Device Problem Non Reproducible Results (4029)

Patient Problem Sudden Cardiac Death (2510)

Event Date 07/02/2020

Event Type  Death  

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 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.

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
• Type of Device: EPOC
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• MDR Report Key: 10315960
• MDR Text Key: 200183216
• Report Number: 3002637618-2020-00038
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00809708052898
• UDI-Public: 00809708052898
• Combination Product (y/n): N
• PMA/PMN Number: K113726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10736387
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1