MAUDE Adverse Event Report: EPOCAL INC. EPOC READER

Model Number HR-1002-00-00

Device Problem Low Test Results (2458)

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

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens has requested further information from the customer, however no response has been received.Therefore no further investigation can be performed.Siemens reviewed the in-house performance for the card lot in question and did not identify any product deficiencies.The cause of this event is unknown.

Event Description

The customer reported discrepant hemoglobin and hematocrit results on their epoc instrument compared to a non-siemens hematology lab 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: 13289016
• MDR Text Key: 287432690
• Report Number: 3002637618-2022-00004
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00809708016685
• UDI-Public: 00809708016685
• Combination Product (y/n): N
• Reporter Country Code: TS
• PMA/PMN Number: K113726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1