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

Model Number HR-1002-00-00

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2021

Event Type  malfunction  

Manufacturer Narrative

The customer stated that they do not measure qc for testing the instrument.Siemens has requested the csv and t-files to be returned for investigation.The customer has responded that they are not available to be returned.The lot # 01-21177-50 will be reviewed for po2 performance.The customer stated they are operational.The cause of this event is unknown.

Event Description

The customer reported discrepant low po2 results on two patients on the epoc reader which did not meet each patient's condition.The clinician did not do repeat testing on the two patients.The customer stated the expected result was to be approximately 80 mmhg.There was no report of injury due to this event.

Manufacturer Narrative

Siemens has evaluated the card lot performance: the in-house performance for the card lot in question, 01-21177-50, was investigated for po2 performance and did not identify any product deficiencies.Card lot 01-21177-50 was tested with arterialized blood with a target po2 of approximately 80 mmhg and with aqueous control fluids eurotrol l1 and eurotrol l3 at the time of product release.Aqueous fluids and arterialized blood displayed no indication of discrepant results at the time of release.There were no other complaints received on card 01-21177-50.Therefore, there is no evidence that the system or reagent cards are not performing as intended.Siemens recommends using the correct reference ranges associated with the sample type collected.According to the data, all of the po2 results were acceptable results for the earlobe capillary sample type used for analysis.Additionally, the customer was using earlobe capillary samples.According to clsi c46-a blood gas and ph analysis and related measurements: approved guideline, arterial blood samples are preferred for blood gas analysis.

• 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
• MDR Report Key: 12526222
• MDR Text Key: 273123585
• Report Number: 3002637618-2021-00055
• 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: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• 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: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1