MAUDE Adverse Event Report: EPOCAL INC. EPOC READER, HOST

Model Number HR-1002-00-00

Device Problem Non Reproducible Results (4029)

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

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results which met the clinical picture and a corrected report was issued.The customer was unable to confirm if proper technique, or sample handling was used.The instrument log files are no longer available for investigation.Investigation into the performance of the test card lot is underway.The cause of this event is unknown.

Event Description

The customer reported discrepant thb results compared to repeat testing on a non-siemens instrument.There is no report of injury due to this event.

Manufacturer Narrative

The customer was unable to provide instrument log files for this issue.Epoc calculated hgb is derived from the hematocrit (hct) reading on the epoc device.Therefore, the investigation focused on hct performance of the card lot 01-20176-40.A review of the in-house performance for the card lot 01-20176-40 did not identify any product deficiencies for hct.The failure rate of lot 01-20176-40 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 cause of this event is unknown.

• Brand Name: EPOC READER, HOST
• Type of Device: EPOC
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• MDR Report Key: 10735760
• MDR Text Key: 213070001
• Report Number: 3002637618-2020-00057
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• 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: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1