MAUDE Adverse Event Report: EPOCAL INC. EPOC READER

Catalog Number	10736401
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has requested log files however this data is not available.The customer states that the instrument is currently operational and believes the discrepant results to be due to improper sample handling.
Event or Problem Description
The customer received discrepant elevated po2 results on two patients compared to retesting on another epoc instrument using the same samples.There is no report of injury due to this event.

• Brand Name: EPOC READER
• Common Device Name: EPOC
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• MDR Report Key: 10290348
• Report Number: 3002637618-2020-00035
• Device Sequence Number: 3162469
• Product Code: CGL
• UDI-Device Identifier: 00809708032333
• UDI-Public: 00809708032333
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 10736401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1