MAUDE Adverse Event Report: EPOCAL INC. EPOC HOST

Model Number HH-1R09-00-00

Device Problem Non Reproducible Results (4029)

Patient Problem Cardiac Arrest (1762)

Event Date 09/05/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens has requested data files for investigation but none have been provided.Since no instrument files could be obtained, lot performance will be assessed.The customer is currently using this epoc device.The customer stated the patient is currently stable.Response from customer: "after much review and testing, we have determined the discrepancy could only have been caused by preanalytical issues.In running ten samples, my correlation for the potassium was quite tight.We have concluded the epoc was not responsible for the mi of that patient.".

Event Description

The customer reported discrepant potassium values on the epoc host when compared to a non-siemens lab instrument.

Manufacturer Narrative

Siemens has requested instrument logs from the customer, however the customer has not provided the requested data.The cause of the k+ discrepancies could not be determined from the information provided by the customer.A review of the inhouse performance for the card lot used, lot 01-20118-10, did not identify any product deficiencies.The failure rate of lot 01-20118-10 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 handling/delays are known to affect sample results if proper precautions are not considered.The cause of this event is unknown.

• Brand Name: EPOC HOST
• Type of Device: EPOC HOST
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• MDR Report Key: 10631223
• MDR Text Key: 221011925
• Report Number: 3002637618-2020-00053
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00809708053901
• UDI-Public: 00809708053901
• Combination Product (y/n): N
• PMA/PMN Number: 113726
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HH-1R09-00-00
• Device Catalogue Number: 10736393
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 YR