Safety Alerts

The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Epocal Inc (Siemens Healthcare Pty Ltd) epoc NXS Host [Software Version: 4.14.9; Serial Number: 11413518; UDI: 00630414605678] [HKMD No.: 210419].

According to the TGA, the manufacturer has confirmed a rare scenario in which the demographic information of a previously analysed patient is displayed with the current Patient ID on the epoc NXS Host screen during Positive Patient Identification (PPID) Lookup. The problem occurs only when all of the following conditions are met:-

• The customer uses PPID; and
• The user performs consecutive tests on patients without logging out or returning to the home page; and
• The connection between the epoc NXS Host and Data Manager (DM) is lost during the PPID Lookup process; and
• The user inadvertently accepts the previous patient’s demographics displayed for the current patient and proceeds with testing.

When these conditions are met, the current patient’s results may be listed with the previous patient’s name and demographic information.

For further information, please visit: https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-01063-1

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 28 November 2024