MAUDE Adverse Event Report: EPOCAL INC. EPOC READER

Model Number HR-1R02-00-00

Device Problem Low Test Results (2458)

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

Event Date 06/14/2022

Event Type  malfunction  

Event Description

The customer reported that their epoc instrument gave a discrepant low sodium result compared to retesting of the same sample on a non-siemens instrument.There is no report of injury due to this event.

Manufacturer Narrative

Siemens has requested instrument files for further investigation however the customer did not provide them.The in-house performance of sodium for the card lot in question was reviewed.Aqueous fluids and arterialized blood performed as expected and met product specifications at the time of release.Additional testing was performed with blood representative of the customer testing range.All epoc test results were centered within the allowable total error and comparable to test results provided by other blood gas analyzers.Differences in instrument methodologies cannot be ruled out as a root cause of the alleged sodium discrepancy(ies) at the customer site.Therefore, there is no evidence that the system or reagent cards are not performing as intended the cause of this event is unknown.

• Brand Name: EPOC READER
• Type of Device: EPOC
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• Manufacturer (Section G): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• Manufacturer Contact: tim krauskopf ; 2 edgewater drive; norwood, MA 02062 ; 6107052212
• MDR Report Key: 15007170
• MDR Text Key: 303704263
• Report Number: 3002637618-2022-00040
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00809708032333
• UDI-Public: 00809708032333
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K113726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HR-1R02-00-00
• Device Catalogue Number: 10736401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Male