MAUDE Adverse Event Report: EPOCAL INC. EPOC BLOOD ANALYSIS SYSTEM; EPOC READER

Catalog Number	11413475
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information provided by the customer, the cause of this event is user error.No further investigation required.
Event or Problem Description
The customer stated that an operator logged into their epoc instrument to run a test on (b)(6) 2024 at 06:50.Patient 1 was scanned, but the user received an error code and was unable to run the test at that time.Another user then used the same epoc instrument to run a test at 12:55 on patient 2, and the original pid for patient 1 was still programmed into the host at the time of testing so the results for patient 2 were sent to the chart of patient 1.The results were questioned by the physician and blood for patient 2 was needed to be recollected for retesting.The ventilator settings for patient 1 were changed due to the incorrect results and were changed back after retesting a 15:47.There is no report of harm due to the change in treatment.

• Brand Name: EPOC BLOOD ANALYSIS SYSTEM
• Common Device Name: EPOC READER
• 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
• MDR Report Key: 18861413
• Report Number: 3002637618-2024-00016
• Device Sequence Number: 19661639
• Product Code: CHL
• UDI-Device Identifier: 00630414606095
• UDI-Public: 630414606095
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K200107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 11413475
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown