MAUDE Adverse Event Report: EPOCAL INC. EPOC READER

Model Number HR-1002-00-00

Device Problem Insufficient Information (3190)

Patient Problem Abnormal Blood Gases (1034)

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

The customer provided the epoc results they considered discrepant, but no comparative results.The customer's complaint of low po2 results with card lot # 01-21035-20 will be investigated by looking at in-house data, finished goods testing, lifetime testing, retain testing and a search to see if there are any other complaints on this same card lot.The customer stated since they have used a new card package of the same lot, they did not observe any further discrepant results and they are operational.The cause of this event is unknown.

Event Description

The customer is alleging discrepant low po2 results on 3 patients on the epoc reader.The customer provided the epoc results they considered discrepant, but no comparative results.The customer stated for elderly ventilated patients, the customer expected values of at least 60 mmhg.For younger patients they expected values of at least 80 mmhg.The customer did not specify which patients are elderly and which are younger.Siemens requested additional information several times but none has been received.The customer stated the samples are collected from the patient's earlobes after the application of finalgon to cause increased blood flow to the area.There is no report of injury due to this event.

Manufacturer Narrative

Siemens has completed the investigation: the cause of the alleged discrepancies could not be identified from the information provided by the customer.A review of the in-house performance for the card lot used, lot 01-21035-20, did not identify any product deficiencies.In addition, there were no other complaints received on card lot 01-21035-20.Therefore, there is no further evidence that the system or reagent cards are not performing as intended.A review of finished goods (fg) test data demonstrates that card lot 01-21035-20 performed as expected for po2 with respect to the target.Overall, the lot had acceptable performance for po2 in both aqueous control fluids tested at the time of lot release.The fg blood results for card lot 01-21035-20 were assessed for evidence of discrepant bias on the oxygen sensor.The fg blood results for card 01-21035-20 also demonstrated acceptable performance for po2.

• 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: 11649264
• MDR Text Key: 245386235
• Report Number: 3002637618-2021-00024
• 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: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• 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
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1