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	11/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has requested instrument files, setup, and information on the patient id barcode for further investigation.The customer stated that they have code 39 and code 128 enabled.For these symbologies, siemens has stated that a check digit must be enabled to prevent scanning errors.The customer has not yet stated what symbology is used for the patient id.The cause of this event is unknown.
Event or Problem Description
The customer alleged that when running a test for a 78 year old female, the results were incorrectly applied to the patient id for an 83 year old male.The customer stated that the test run prior to this mix up was for the 83 year old male.The error was noticed immediately and there was no change to patient treatment or diagnosis.The test was correctly rerun for the 78 year old female.There is no report of injury due to this event.
Additional Manufacturer Narrative
The customer was not able to provide all of the requested information needed to confirm if a software issue occurred on the epoc instrument.During the review of the information the custom did provide, no evidence could be found that the alleged issue took place on the device.No further investigation can be performed without all of the requested data.No product problem found.

• 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: 18190853
• Report Number: 3002637618-2023-00100
• Device Sequence Number: 12397392
• Product Code: CHL
• UDI-Device Identifier: 00630414606095
• UDI-Public: 630414606095
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 01/22/2024

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: 11/14/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 01/22/2024
• 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 Age: 78 YR
• Patient Sex: Unknown