MAUDE Adverse Event Report: EPOCAL INC. EPOC READER

Catalog Number 10736398

Device Problem Non Reproducible Results (4029)

Patient Problem Insufficient Information (4580)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens has completed the investigation: the cause of the hematocrit (hct) discrepancy could not be determined from the information provided by the customer.A review of the in-house performance (including retain testing) for the card lot used, 10-20216-20, did not identify any product deficiencies.The failure rate of lot 10-20216-20 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.The csv files provided by the customer offered additional insights and brought value to the investigation.From the information provided by the customer, there are a few factors that may have contributed to a discrepant hct reading.Firstly, different sample draws (collection site, collection method, time delays), sample handling and testing delays are known to affect test results if proper precautions are not considered.On 12 nov 2020, it was indicated that the epoc sample was tested at 5:41 am, resulting in an iqc failure (sample delivery failure).The same sample was then tested again at 5:47 am on epoc (6 min delay), providing the hct result of 27 %pcv.It should be noted that delays in testing a drawn blood sample in the absence of anticoagulant increase the risk associated with clotting and mixing (sample handling) related issues - which in turn can lead to discrepant readings.Secondly, the methods of hct measurement are not the same with epoc and the comparative instrument.Sysmex uses a complete blood cell count (cbc) method, which has known limitations associated with the calculation of falsely elevated values when a high reticulocyte or white blood cell (wbc) count is present.This is because the higher cell volumes of wbcs/ reticulocytes can interfere with the rbc count and thus falsely increase the hct reading.The customer has confirmed the patient's reticulocyte count was slightly elevated and wbc count was high, therefore, the impact/contribution of this measurement method cannot be ruled out as a potential elevated result on the sysmex.Thirdly, it was indicated by the customer that the sysmex xn 3000 utilized a sample with k2 edta anticoagulant.It is well documented in literature that the mean cell volumes of k3 edta anticoagulated blood are approximately 4% less than k2 edta anticoagulated blood.While the choice of anticoagulant affects the microhematocrit method to which all hematocrit methods are calibrated, results from routine samples on hematology analyzers are independent of the anticoagulant used.Since most clinical hematology analyzers are calibrated by the microhematocrit method using k3 edta anticoagulant, the epoc system is calibrated to a k3 edta microhematocrit method.If the sysmex instrument is calibrated to k2 edta anticoagulated blood, it will read ~4% higher than epoc.In these situations epoc advises a correction factor of 1.045 (e.G.K2 edta sysmex / 1.045).

Event Description

The customer reported a discrepant hematocrit result on a neonate on the epoc reader when compared to the result on a non-siemens hematology instrument.There was no report of injury due to this event.

• Brand Name: EPOC READER
• Type of Device: EPOC
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• Manufacturer (Section G): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062 ; 6107052212
• MDR Report Key: 10905601
• MDR Text Key: 221012020
• Report Number: 3002637618-2020-00067
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00809708121860
• UDI-Public: 00809708121860
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10736398
• Date Manufacturer Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1