MAUDE Adverse Event Report: EPOCAL INC. EPOC HOST

Catalog Number 10736387

Device Problem Non Reproducible Results (4029)

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

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation results: the cause of the chgb discrepancy could not be determined from the information provided by the customer.A review of the in-house performance for the card lot used, lot 01-20029-20, did not identify any product deficiencies.The failure rate of lot 01-20029-20 is not showing an increased trend in the field, therefore there is no further evidence that the system or reagent cards are not performing as intended.The customer's instrument is not currently in use as it was returned it to the repair facility.The customer received a replacement and is operational with a new instrument at this time.The cause of this event is unknown.

Event Description

The customer reported discrepant total hemoglobin results on the epoc host when compared to a non-siemens lab instrument.There is 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 ; 7052212
• MDR Report Key: 10286296
• MDR Text Key: 199514629
• Report Number: 3002637618-2020-00034
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00809708052898
• UDI-Public: 00809708052898
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10736387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2020
• 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: N
• Patient Sequence Number: 1