| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01001-1 |
| Product Name/Description |
RAPIDPoint 400 Series, RAPIDPoint 500, and RAPIDLab 1200 Series Analysers (diagnostic blood gas analyser)
ARTG Number: 174383 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/09/2013 |
| Responsible Entity |
|
| Reason/Issue |
According to reports received by Siemens, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample.
Patient ID mismatches could be caused by the following:
1. Inadvertently accepting the pre-selected patient ID on the demographics screen.
2. Overwriting sample demographics by incorrect operation of the Patient List button.
3. Scanning the wrong barcode.
4. Manually typing the wrong barcode.
In each of these cases, failure to check the correct demographics before moving on to the results screen will assign the wrong demographics to the sample being tested. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing work around instructions for users to follow in the event that patient ID mismatch occurs. A software update will be available for RAPIDPoint 400 series and RAPIDPoint 500 analysers in January 2014. Software version 3.2 and over which are currently available for RAPIDLab 1200 Series analyser addresses the issues. This action has been closed-out on 28/04/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |