MAUDE Adverse Event Report: EPOCAL INC. EPOC READER

Catalog Number 10736401

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2020

Event Type  malfunction  

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 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
• 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: felix akinrinola ; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10290348
• MDR Text Key: 199514661
• Report Number: 3002637618-2020-00035
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00809708032333
• UDI-Public: 00809708032333
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10736401
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1