MAUDE Adverse Event Report: EPOCAL INC. EPOC READER AND POWER SUPPLY

Model Number HR-1002-00-00

Device Problem Non Reproducible Results (4029)

Patient Problem Insufficient Information (4580)

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens investigation has been completed: the in-house performance for the card lot in question, 11-21110-30, did not identify any product deficiencies.When the correct reference ranges are applied, only po2 for patient 2 met psi criteria in the customer complaint.Therefore, the investigation focused on the in-house epoc performance for po2.Card lot 11-21110-30 was tested with arterialized blood and with aqueous control fluids eurotrol l1 and eurotrol l3 at the time of product release.Aqueous fluids and arterialized blood displayed no indication of discrepant results at the time of release.Aqueous fluids eurotrol l1 and l3 were tested on card lot 11-21110-30 throughout the product lifetime and displayed no indication of discrepant results.In addition, there were no other complaints received on card 11-21110-30.Therefore, there is no evidence that the system or reagent cards are not performing as intended.

Event Description

The customer reported a discrepant high po2 result on the epoc when compared to a pulse oximeter.There is no report of injury due to this event.

• Brand Name: EPOC READER AND POWER SUPPLY
• Type of Device: EPOC READER
• 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 ; 6107052212
• MDR Report Key: 12475783
• MDR Text Key: 271519528
• Report Number: 3002637618-2021-00049
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00809708016685
• UDI-Public: 00809708016685
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HR-1002-00-00
• Device Catalogue Number: 10736398
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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