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

Model Number HR-1002-00-00

Device Problem Low Test Results (2458)

Patient Problem Insufficient Information (4580)

Event Date 09/20/2021

Event Type  malfunction  

Manufacturer Narrative

The in-house performance for the card lot in question, 01-21201-50, did not identify any product deficiencies.The investigation focused on the in-house epoc performance for po2.Card lot 01-21201-50 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 performed as expected and met product specifications at the time of release.In addition, there were no other complaints received on card 01-21201-50.Therefore, there is no evidence that the system or reagent cards are not performing as intended.Additionally, it was noted the customer was using earlobe capillary samples.The process of capillary collection may change po2 levels significantly and is susceptible to factors such as air contamination.According to clsi c46-a blood gas and ph analysis and related measurements: approved guideline, arterial blood samples are preferred for blood gas analysis.No comparative value was obtained after the patient received oxygen.Without a true value, there is not enough information to allege the epoc was not performing as it was intended.Patients with low oxygen saturation may encounter increased oxygen extraction, which could present as a lower venous or capillary sample than expected.Additionally, no comparative value was obtained for the po2 result prior to receiving oxygen so it is not possible to determine if that result was correct given the sample type used.There is not enough evidence that points to a systemic product problem and there are many variables introduced when capillary blood is used for blood gas analysis.It should also be noted that the customer's qc was out of range prior to patient analysis.The cause of the event is unknown.

Event Description

The customer reported discrepant low po2 results for one patient on the epoc reader after receiving two liters of oxygen for 15 minutes.The samples were taken from the earlode using a capillary tube.It should be noted that the customer's qc was out of range low prior to patient analysis.The customer stated the physician expected a result above 60 mmhg.Due to limited information in addition to the fact that no comparative value was obtained after the patient received oxygen, this complaint is being filed out of an abundance of caution.There is no report of injury due to this event.

• Brand Name: EPOC READER & 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: 12632796
• MDR Text Key: 276603612
• Report Number: 3002637618-2021-00060
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00809708016685
• UDI-Public: 00809708016685
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• 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: 09/21/2021
• 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