MAUDE Adverse Event Report: EPOCAL INC. EPOC HOST

Model Number HH-1009-00-00

Device Problem Non Reproducible Results (4029)

Patient Problem Abnormal Blood Gases (1034)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results which met the clinical picture and a corrected report was issued.The poc specialist observed how the nurses were running the blood gases on the epoc.Many of the nurses were collecting the specimen, then putting it on ice.The customer stated that in the epoc manual, the epoc is designed as a point of care device, and the sample should never be put on ice.The manual explains that iced specimens can erroneously increase the ph.The customer stated that the correction was made with the entire nursing staff and has not seen the issue of discrepant high ph since.The customer is not requesting further action or investigation and is attributing the issue to not properly training the nursing staff.

Event Description

The customer reported discrepant high ph results on the epoc host when compared to results on another siemens lab instrument, the rapid lab 1265.There was no report of injury due to this event.

• Brand Name: EPOC HOST
• Type of Device: EPOC HOST
• 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 ; 2 edgewater drive; norwood, MA 02062 ; 6107052212
• MDR Report Key: 10984903
• MDR Text Key: 220716967
• Report Number: 3002637618-2020-00068
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00809708052898
• UDI-Public: 00809708052898
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HH-1009-00-00
• Device Catalogue Number: 10736387
• Date Manufacturer Received: 11/12/2020
• 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