MAUDE Adverse Event Report: EPOCAL INC. EPOC READER

Catalog Number 10736398

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

The hct and hgb performance for card lot 00-19193-10 will be investigated.The customer stated they are operational.The cause of this event is unknown.

Event Description

The customer reported discrepant hematocrit and hemoglobin results on the epoc reader when compared to a repeat on the same instrument and a non-siemens lab analyzer.There was no report of injury due to this event.

Manufacturer Narrative

The raw waveform data (provided by customer) was analyzed.Based on the limited information available, it is possible a blood clot or sample injection issue occurred on the test in question, indicating more of a sample handling/user injection related issue than a product deficiency.The cause of the discrepancy could not be determined.A review of the in-house performance of the card lot in use, lot 00-19193-10, did not identify any product deficiencies.In addition, a search of the complaint handling system (gsms) for the card lot did not return any other related complaints.Therefore, we conclude that there is no indication of a failure of the system to perform as intended.The customer is operational.

• Brand Name: EPOC READER
• Type of Device: EPOC
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, K1G 3 P5; CA K1G 3P5
• MDR Report Key: 9419056
• MDR Text Key: 174172861
• Report Number: 3002637618-2019-00127
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00809708016685
• UDI-Public: 00809708016685
• Combination Product (y/n): N
• PMA/PMN Number: K113726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10736398
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR