MAUDE Adverse Event Report: EPOCAL INC. EPOC READER

Model Number HR-1002-00-00

Device Problem Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

The customer has provided the expected results however no comparative test were run.The customer has provided instrument files and the investigation is currently underway.The customer has stated that they are currently operational.The cause of this event is unknown.

Event Description

The customer alleges discordant hct test results when using the epoc reader sn (b)(4).The customer performed seven readings over the course of a patient's procedure, cardio pulmonary bypass.The customer is questioning results #3-7.The customer stated that the expected value for result #3 was 19-20%hct and that the expected value for result #6 was 25-27%hct.There was no report of injury due to this event.

Manufacturer Narrative

Siemens has completed the investigation: the cause of the hematocrit discrepancy could not be determined from the information provided by the customer.The customer provided csv files including results for analytes other than hct.The customer could only provide raw data for failed tests.Without raw data (t_files) for the alleged discrepant results, it is not possible to reach a conclusive cause.A review of the in-house performance for card lot 10-21060-20 did not identify any product deficiencies.There was no indication of discrepant results at the time of product release (finished goods testing) nor during lifetime stability testing or retain lot testing.In addition, there were no other complaints received on card lot 10-21060-20.Therefore, there is no evidence that the system or reagent cards are not performing as intended.Sample handling (such as collection vessel, mixing and method of collection) are known to affect test results if proper precautions are not considered.The customer indicated that several samples were obtained directly from the bypass machine.It should be noted that improper sample mixing, including sample collection from a source with a non-uniform concentration can contribute to variation in test results and cannot be ruled out as a contributing factor.

• 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: 12017116
• MDR Text Key: 256747680
• Report Number: 3002637618-2021-00039
• 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: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HR-1002-00-00
• Device Catalogue Number: 10736398
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1