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	03/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens requested for more information and data files from the customer.However, customer provided insufficient information & the cause of the hematocrit (hct) and hemoglobin (hgb) discrepancy could not be determined from the information provided by the customer.Epoc calculated hgb is derived from the hematocrit (hct) reading on the epoc device.As per section 12.16.6 of the epoc system manual; hemoglobin concentration is calculated from the measured hematocrit according to the relation: chgb (g/dl) = hct (decimal fraction) x 34.Given this relation, the investigation focused solely on hct performance of the card lot 04-23018-60.The in-house performance of hct for the card lot in question, 04-23018-60, did not identify any product deficiencies.Card lot 04-23018-60 was tested with blood and with aqueous control fluids at the time of product release.Card lot 04-23018-60 met product specifications at the time of release.There is no evidence that the system or reagent cards are not performing as intended.The cause of the event is unknown.
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.

• 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: 16913914
• Report Number: 3002637618-2023-00027
• Device Sequence Number: 2189060
• 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): 05/11/2023

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: 04/14/2023
• Initial Report FDA Received Date: 05/11/2023
• 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 Age: 50 YR
• Patient Sex: Male