MAUDE Adverse Event Report: EPOCAL INC. EPOC HOST 2 JAPAN; EPOC BARCODE READER

Catalog Number 10736390

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens sales went onsite.The customer is using codabar which is an approved barcode symbology for epoc.The customer, while holding the clear file, read the barcode over the clear file.This is why the barcode can be curved when read.Since the customer is reading the barcode over the clear file with using the codabar, there might be the possibility of misreading.The customer has been advised to read the barcode without the clear file.Sales read the barcode again and found the issue was not reproducible.The customer has been advised that the use of a barcode with a check digit would help to prevent this error.They have also been advised not to scan the barcode while in a clear file to avoid curving or glare that may cause this issue.The customer is satisfied.The instrument is operational.

Event Description

The customer reported the epoc barcode reader mis-scanned the patient id and results from patient #1 were sent to patient #2.Patient #2 did not have these tests on this day.The customer noticed the error and reran patient #1.Repeat test results were sent to the correct patient (patient #1).There was no report of harm or incorrect treatment to either patient as a result of this event.

• Brand Name: EPOC HOST 2 JAPAN
• Type of Device: EPOC BARCODE READER
• 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: felix akinrinola ; 2 edgewater drive; norwood, MA 02062 ; 6107052212
• MDR Report Key: 9306240
• MDR Text Key: 167046492
• Report Number: 3002637618-2019-00118
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00809708075576
• UDI-Public: 00809708075576
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Type of Report: Initial
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10736390
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2019
• 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