MAUDE Adverse Event Report: EPOCAL INC. EPOC READER & POWER SUPPLY

Model Number HR-1002-00-00

Device Problem Non Reproducible Results (4029)

Patient Problem Insufficient Information (4580)

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens has completed the investigation: the in-house performance for the card lot in question, 01-21087-10, did not identify any product deficiencies.Card lot 01-21087-10 was tested with arterialized blood (hct ~38%) and with aqueous control fluids eurotrol l1 and eurotrol l3 at the time of product release.Aqueous fluids and arterialized blood displayed no indication of discrepant results at the time of release.Retain testing was also performed on card lot 01-21087-10 with a blood sample prepared in-house to achieve a target hematocrit level of ~20-30% to mimic the customer testing range.Retain testing was tested vs.Spun hct and showed no indication of discrepant results.In addition, there were no other complaints received on card 01-21087-10.Therefore, there is no evidence that the system or reagent cards are not performing as intended.Note: it is possible the methods of hct measurement are not the same with epoc and the comparative laboratory instrument.It is unsure whether the comparative instrument 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 comparative instrument printout provided by the customer indicated the patient's wbc count was flagged as high, therefore, the impact/contribution of this measurement method cannot be ruled out as a potential elevated result.

Event Description

The customer reported discrepant hemoglobin and hematocrit results for one patient on the epoc reader when compared to a non siemens hematology analyzer.There was no report of injury due to this event.

• Brand Name: EPOC READER & POWER SUPPLY
• 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: 12238997
• MDR Text Key: 264072382
• Report Number: 3002637618-2021-00041
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00809708016685
• UDI-Public: 00809708016685
• 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: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• 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
• Date Manufacturer Received: 07/07/2021
• 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