| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00499-1 |
| Product Name/Description |
RAPIDPoint 500 Blood Gas Analyser with V2.4 Software
Siemens Material Numbers (SMN): 10492730, 10696857, 10697306
ARTG Number: 175890 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has identified an issue with RAPIDPoint 500 Blood Gas Analysers with V2.4 software. There is a potential to misassign patient demographic information (Last Name, First Name, Gender or Date of Birth) when the Patient ID field is left “blank” on multiple patient samples and a recall of the patient information is initiated. As stated in the RAPIDPoint 500 Operators Guide, the Patient ID field is a “required” field, and the Patient ID field is set as “required” when the RAPIDPoint 500 analyser is shipped from Siemens.
There is a risk to health based upon the potential misclassification of a patient as having falsely abnormal test results receiving additional diagnostic testing and treatment, as well as the risk of a patient who has abnormal results being incorrectly identified as having normal results based upon incorrect sample identification. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens Healthcare is currently developing a software update to address this issue and will be providing new information as it becomes available. In the interim, Siemens is advising users to maintain the Patient ID field as enabled and a “required” Patient Demographic entry on their RAPIDPoint 500 analyser. If the Patient ID field on the RAPIDPoint 500 analyser is not set as “required,” reset it to “required” by following the instructions provided in the customer letter. If the laboratory has run samples from multiple patients with the Patient ID field blank, Siemens recommends a review of those previously generated results.
This action has been closed out on the 27/11/2018. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |