MAUDE Adverse Event Report: EPOCAL INC. EPOC HOST

Model Number	HH-1009-00-00
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	Abnormal Blood Gases (1034)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: EPOC HOST
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• MDR Report Key: 10984903
• Report Number: 3002637618-2020-00068
• Device Sequence Number: 792094
• Product Code: CGL
• UDI-Device Identifier: 00809708052898
• UDI-Public: 00809708052898
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K113726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 12/10/2020

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 Model Number: HH-1009-00-00
• Device Catalogue Number: 10736387
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1