MAUDE Adverse Event Report: EPOCAL INC. EPOC READER

Model Number HR-1002-00-00

Device Problem Non Reproducible Results (4029)

Patient Problem Insufficient Information (4580)

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results which met the clinical picture.The customer's complaint of low po2 results with card lot # 01-21041-20 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 cause of this event is unknown.

Event Description

The customer reported a discrepant low po2 result on the epoc reader when compared to an rp 500 instrument.There was 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 01-21041-20, did not identify any product deficiencies.In addition, there were no other complaints received on card lot 01-21041-20.Therefore, there is no further evidence that the system or reagent cards are not performing as intended.The bias noted at the customer site could be due to the cumulative effect of multiple causes: different sample draws and delays between collection and analysis are known to affect test results if proper precautions are not considered.Given the sample draws were different for epoc and rp500, and the collection times are unknown, these cannot be ruled out as contributing factors.Additionally, the epoc and rp500 tests were not performed side-by-side, and there was 1 hour delay between tests.It is possible there were changes to the patient's condition during this time.There can be differences in bias between different instruments/platforms.It was noted that qc did not pass on epoc at the customer site, and incorrect rilibak ranges were used.If the customer is concerned on lot performance, it is recommended the customer perform valid qc procedures prior to blood testing.According to clsi c46-a blood gas and ph analysis and related measurements; approved guideline, it is recommended 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, the guideline indicates that in cases where "arterialized" capillary blood may be the only practical alternative to arterial blood, the blood gas results should be interpreted cautiously.In addition to sample inadequacies, the process of capillary collection may change po2 levels significantly.

• Brand Name: EPOC READER
• Type of Device: EPOC
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• MDR Report Key: 11761211
• MDR Text Key: 248547320
• Report Number: 3002637618-2021-00030
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• 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