Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2016-RN-01098-1
Product Name/Description RAPIDPoint 400/405/500 Systems and RAPIDLab 1240/1245/1260/1265 Systems (blood gas analysers). An in vitro diagnostic medical device (IVD).

Various models affected

ARTG Number: 175890
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 22/08/2016
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue Siemens has identified that when all of a particular set of steps occur there is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even when those fields have been turned Off for the system. The steps are:

1. Analyser is configured with patient demographics (last name, first name) disabled and Rapid Sample Identification Transaction (host query) turned on.
2. Patient ID barcode is scanned at Analysis screen prior to sample being analysed and is not the barcode for the patient sample being tested.
3. Patient ID and Last Name are not confirmed and/or corrected at the Analysis screen.
4. The sample is analysed and correct Patient ID is entered at Demographics screen.

An incorrect patient name on the blood gas printout has the potential to lead to patient mismanagement.

The patient ID and patient test result data are correct on the analyser screen and the LIS.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens is advising users to not configure the Siemens Blood Gas Analyser with the patient demographics (last name, first name) turned Off and the Rapid Sample Identification Option turned On. In addition, if sample IDs are scanned at the analysis screen, users should confirm that the patient ID is correct on the screen prior to analysing the sample. And, if the patient ID is not correct, correct it at the analysis screen.

This action has been closed out on 08/11/2018
Contact Information 1800 310 300 - Siemens Technical Support Centre