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

Catalog Number	11413475
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer provided instrument csv files, however these were insufficient to be used for further investigation.However, based on the details provided by the customer, this event appears to be in scope of a confirmed software issue with the epoc system.When a new test is run which re-uses the database test id of a previously run test that was deleted by the test retention feature, any result in the deleted test that is not an analyte in the new test will be pulled in and displayed as part of the new test, this includes measured, calculated, and corrected results.Siemens is taking action to address this issue.It is estimated that the probability of occurrence for this issue is low as there is a very specific sequence of events that must be met for this software issue to occur.A field action poc 24-001 "potential for test record to include unselected analytes" was released on october 19, 2023.Crr # 3002637618-10-19-2023-003-c.Another instance of this issue for the same customer on a different instrument which had the same set up, was documented in mdr 3002637618-2023-00088.
Event or Problem Description
The customer alleged that their data manager presented all results for the entire test panel, and not just the ones they selected when running their epoc instrument.The customer later reported that their instrument was operating as intended after updating the configuration of their data manager.At that time, this was believed to be an issue with the data manager.On (b)(6), during the investigation of another complaint, a software issue was found.A review of the information provided by this customer determined that this complaint was in scope, and it was therefore re-escalated.

• Brand Name: EPOC BLOOD ANALYSIS SYSTEM
• Common Device Name: EPOC NXS HOST
• 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: 18015596
• Report Number: 3002637618-2023-00089
• Device Sequence Number: 7582504
• Product Code: CHL
• UDI-Device Identifier: 00630414606095
• UDI-Public: 630414606095
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 10/26/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3002637618-10-19-2023-00
• Patient Sequence Number: 1
• Patient Sex: Unknown