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

Catalog Number 10736398

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2023

Event Type  malfunction  

Event Description

The customer is alleging receiving discrepant low potassium, and hematocrit on a patient from siemens epoc device as compared to other non-siemens devices.There was no report of injury due to this event.

Manufacturer Narrative

Siemens requested for more information and data files from the customer.However, the customer has closed out this escalation on their end due to user error, therefore only the certificate of analysis was reviewed for card lot 04-23058-50.Upon review, the card lot passed all fluid level testing.As a result, there is no evidence that the card lot was not performing as intended at the time of release.The cause of the event is unknown.

• Brand Name: EPOC READER
• Type of Device: 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: felix akinrinola ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 17618728
• MDR Text Key: 321972756
• Report Number: 3002637618-2023-00069
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 00809708016685
• UDI-Public: 00809708016685
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/24/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 10736398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female