MAUDE Adverse Event Report: EPOCAL INC. EPOC HOST

Catalog Number	10736387
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's wristband was corrected, but the results in the epoc and edm were still mismatched to another patient.The customer called into siemens technical solutions to determine if and how patient results can be edited, however, the customer was told that only a comment can be added to describe the event.No lab tests were performed on the other baby.There is no allegation of any harm or adverse events and no patient results or treatments were affected.The system is operational and the event is classified as a use/user error (accidental misuse).
Event or Problem Description
The customer stated a nicu nurse drew a heel stick sample and ran an epoc cap-care tube, pt.Id# (b)(6).The results were not transferring over into the patient's chart (powerchart emr), and it was then discovered that the patient had another patient wristband on, pt.Id# (b)(6).The incorrect barcode was scanned.The patient's wristband was corrected, but the results in the epoc and edm were still mismatched to another patient.There were no lab tests performed on the other baby.No treatment or lack of treatment occurred as a result of the user error.

• Brand Name: EPOC HOST
• Common Device Name: EPOC
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• MDR Report Key: 9765338
• Report Number: 3002637618-2020-00007
• Device Sequence Number: 687653
• Product Code: CGL
• UDI-Device Identifier: 00809708052898
• UDI-Public: 00809708052898
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/27/2020

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: 10736387
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2020
• Initial Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1