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

Catalog Number 11413475

Device Problem Use of Device Problem (1670)

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

Event Date 01/28/2024

Event Type  malfunction  

Manufacturer Narrative

Based on the information provided by the customer, the cause of this event is user error.No further investigation required.

Event 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
• Type of Device: 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
• MDR Text Key: 337696702
• Report Number: 3002637618-2024-00016
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 00630414606095
• UDI-Public: 630414606095
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200107
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11413475
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1