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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results and a corrected report was issued.It is stated in the complaint that the customer is unable to share data and the requested electronic communication.The cause of this event is unknown.

Event Description

The customer reported discrepant high ph results on the epoc reader when compared to a non-siemens lab analyzer.There is no report of injury due to this event.

Manufacturer Narrative

Siemens completed their review: the cause of the ph discrepancy was likely attributed to the customer keeping samples on ice prior to analysis.The customer has since discontinued the use of ice and noticed that the ph results are now matching between instruments.A review of the in-house performance for the card lot in question, 10-20262-40, did not identify any product deficiencies.The card lot was tested with blood in the normal range for ph (7.1-7.5) and with aqueous control fluids eurotrol l1 and eurotrol l3 at the time of product release.Aqueous fluids and normal blood displayed no indication of discrepant results at the time of release.Normal blood was also tested on lot 10-20262-40 throughout the product lifetime, and showed no indication of discrepant results.The failure rate for card lot 10-20262-40 is not showing an increased trend in the field, therefore, there is no further evidence that the system or reagent cards are not performing as intended.As mentioned by the customer, the epoc samples were transported on ice.As discussed in section 12.2.6 of the epoc manual, non-iced samples are recommended and "iced samples may cause increased ph internal quality control failures".Additionally, sample handling and time delays are known to affect sample results if proper precautions are not considered.It is recommended that samples collected in heparinized syringes are tested in less than 30 minutes.

• 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
• MDR Report Key: 11015626
• MDR Text Key: 223475442
• Report Number: 3002637618-2020-00071
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00809708016685
• UDI-Public: 00809708016685
• Combination Product (y/n): N
• PMA/PMN Number: K113726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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
• Date Manufacturer Received: 01/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1