MAUDE Adverse Event Report: EPOCAL INC. EPOC BLOOD ANALYSIS SYSTEM

Catalog Number	10736401
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2018
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.Siemens reviewed the in-house performance of the card lot and was found to be acceptable.The customer is advised to conduct a method comparison between epoc and the non-siemens lab instruments.As per the epoc user manual section 12.13.7 d, "blood samples must be well mixed in order to obtain accurate hematocrit results".The cause of this event is unknown.
Event or Problem Description
The customer reported discrepant hemoglobin results on the epoc blood analysis system when compared to two non-siemens hematology lab analyzers.There was no report of injury due to this event.

• Brand Name: EPOC BLOOD ANALYSIS SYSTEM
• Common Device Name: EPOC
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, K1G 3 P5; CA K1G 3P5
• MDR Report Key: 8384067
• Report Number: 3002637618-2019-00025
• Device Sequence Number: 10867755
• Product Code: CDS
• UDI-Device Identifier: 00809708032333
• UDI-Public: 00809708032333
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2019

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2019
• Initial Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR