MAUDE Adverse Event Report: EPOCAL INC. EPOC READER

Catalog Number 10736398

Device Problems Insufficient Information (3190); Non Reproducible Results (4029)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens has requested data files to be sent for investigation.The customer stated that no instrument data is available.Siemens then asked if the encrypted test records could be extracted? instructions have been sent to the customer.These are result files that remain on the host and does not cross over to the data manager.The cause of this event is unknown.

Event Description

The customer reported discrepant po2 results on two patients when tested on the epoc reader s/n (b)(4).The patients were first analyzed without oxygen supply.Then the patients were given 2l of oxygen for 15 minutes.Then the patients were tested again.The physician felt the results were too high after oxygen therapy due to knowing the patients histories.There was no report of injury due to this event.

Manufacturer Narrative

The customer was unable to provide the requested encrypted test records.A review of the in-house performance for the card lot used, lot 01-20121-10, did not identify any product deficiencies.The failure rate of lot 01-20121-10 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.The customer has been advised that blood gas measurements for the purpose of evaluating the gas exchange function of the lungs (po2 and pco2) should be performed on arterial blood only.Furthermore, in cases where "arterialized" capillary blood may be the only practical alternative to arterial blood, the blood gas results should be interpreted cautiously.

• Brand Name: EPOC READER
• Type of Device: EPOC READER
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• MDR Report Key: 10422654
• MDR Text Key: 203497866
• Report Number: 3002637618-2020-00043
• 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
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• 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
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1