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

Model Number HR-1002-00-00

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/17/2022

Event Type  malfunction  

Event Description

The customer reported being exposed to cal fluid and blood after removing test card from device.Customer believes the event may have happened due to overfilled sample port.The user's eyes and arms came into contact with the fluids.The user flushed their eyes and cleaned their arms afterwards.User was put on antiviral medications.

Manufacturer Narrative

Siemens has requested more information, instrument data files and the test card for further investigation.However, the customer has not responded and therefore no investigation is possible.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
• Manufacturer (Section G): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• Manufacturer Contact: thomas myers ; 2 edgewater drive; norwood, massachusetts 02062 ; CA 02062
• MDR Report Key: 14677875
• MDR Text Key: 301375324
• Report Number: 3002637618-2022-00038
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 05/26/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention