MAUDE Adverse Event Report: EPOCAL INC. EPOC HOST

Model Number	HH-1R09-00-00
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	09/05/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported discrepant potassium values on the epoc host when compared to a non-siemens lab instrument.
Additional 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
• Common Device Name: EPOC HOST
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• MDR Report Key: 10631223
• Report Number: 3002637618-2020-00053
• Device Sequence Number: 14104550
• Product Code: CGL
• UDI-Device Identifier: 00809708053901
• UDI-Public: 00809708053901
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: 113726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HH-1R09-00-00
• Device Catalogue Number: 10736393
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR