MAUDE Adverse Event Report: EPOCAL INC. EPOC READER

Catalog Number 10736398

Device Problem Non Reproducible Results (4029)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results and a corrected report was issued.Siemens has requested the card lot number used, needed for investigation and additional information to properly assess this event.Also stated by the customer is "no qc has been performed on epoc since 2017".The cause of this event is unknown.

Event Description

The customer reported discrepant low potassium results on the epoc reader when compared to a non-siemens lab analyzer.The customer stated patient treatment was affected: potassium via central line catheter was delivered at a higher dose based on the epoc result instead of delivering a lower oral dose based on the lab results.The was no reported injury to the patient due to this event.

Manufacturer Narrative

The results from the in-house retain testing (sensor configuration 35.N) were found to be normal and well within product specifications with no observable irregularities in testing or during data analysis.The epoc potassium performance on card lot 10-19324-30 was deemed to be acceptable, with no product deficiencies identified.The cause of the discrepancy could not be determined from the information provided by the customer, but there is some suggestion that the sample presented to the epoc system may have had clotting or mixing related issues.The failure rate of lot 10-19324-30 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.

• Brand Name: EPOC READER
• Type of Device: EPOC
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• MDR Report Key: 9741007
• MDR Text Key: 180903193
• Report Number: 3002637618-2020-00005
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00809708016685
• UDI-Public: 00809708016685
• 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: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10736398
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 18 YR