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

Catalog Number	10736390
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: EPOC BARCODE READER
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, K1G 3 P5; CA K1G 3P5
• MDR Report Key: 9306240
• Report Number: 3002637618-2019-00118
• Device Sequence Number: 1864750
• Product Code: CGL
• UDI-Device Identifier: 00809708075576
• UDI-Public: 00809708075576
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113726
• 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): 11/11/2019

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: 10736390
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1