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

Catalog Number 10736401

Device Problem Non Reproducible Results (4029)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2018

Event Type  malfunction  

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 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
• Type of Device: EPOC
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, K1G 3 P5; CA K1G 3P5
• Manufacturer (Section G): EPOCAL INC.; 2060 walkley road; ottawa, K1G 3 P5; CA K1G 3P5
• Manufacturer Contact: tim krauskopf ; 2 edgewater drive; norwood, MA 02062 ; 8622285388
• MDR Report Key: 8384067
• MDR Text Key: 139209012
• Report Number: 3002637618-2019-00025
• Device Sequence Number: 1
• Product Code: CDS
• UDI-Device Identifier: 00809708032333
• UDI-Public: 00809708032333
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 67 YR