MAUDE Adverse Event Report: EPOCAL INC EPOC READER; ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Model Number	HR-1R04-00-00
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer is alleging receiving discrepant high chgb and hct on a patient from siemens epoc device as compared to non-siemens instrument.There was no report of injury due to this event.
Additional Manufacturer Narrative
Siemens requested for more information and data files from the customer.Customer did not respond to siemens requests.Siemens is unable to conduct an investigation.The cause of this event is unknown.

• Brand Name: EPOC READER
• Common Device Name: ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
• Manufacturer (Section D): EPOCAL INC; 2060 walkley road; ottawa, ontario K1G3P 5; CA K1G3P5
• Manufacturer (Section G): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G3P 5; CA K1G3P5
• Manufacturer Contact: thomas myers ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 16921414
• Report Number: 3002637618-2023-00028
• Device Sequence Number: 6921585
• Product Code: CHL
• UDI-Device Identifier: 00809708116712
• UDI-Public: 00809708116712
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2023

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 Model Number: HR-1R04-00-00
• Device Catalogue Number: 10736404
• 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: 04/13/2023
• Initial Report FDA Received Date: 05/12/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown