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	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer stated that when pulling results on their nxs host history page for a patient test where only creatinine and egfr (estimated glomerular filtration rate) were run, results for other analytes that were not requested were also presented.These results are also sent to their data manager.Customer stated that while the results were posted to the patient's chart, the patient was not treated based on the results that were inappropriately posted.There is no report of injury due to this event.
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.

• 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: 18012534
• Report Number: 3002637618-2023-00087
• Device Sequence Number: 7314021
• Product Code: CHL
• UDI-Device Identifier: 00630414606095
• UDI-Public: 00630414606095
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• 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
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (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