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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00700-1
Product Name/Description RAPIDPoint 500 Blood Gas Analyzer

Siemens Material Numbers (SMN): 10492730, 10696855, 10696857, 10697306

ARTG Number: 175890

An in vitro diagnostic medical device (IVD)
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 31/07/2015
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue Siemens is informing customers of potential issue when both ports (Serial and Ethernet) are configured to transmit data, the data stream from one port could potentially affect the data stream from the other port. This could cause the message received by the LIS (data management system) to include either: Duplicate data, Missing data and Data from a different patient. The risk to health is limited to the extremely unlikely situation in which an analyte is switched between two patients. A transposed sodium, potassium, glucose, lactate, carboxyhemoglobin, methemoglobin, or neonatal bilirubin result may lead to a potential risk to health when the true value is critical.

In all cases, the probability of occurrence is extremely unlikely due to the low frequency of the software issue and correlation with patient clinical presentation, history, and concurrent laboratory testing.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens is providing end users with instructions on how to disable Dual Port LIS transfer. The resolution of this issue will be addressed in the next software update.
This action has been closed-out on 01/03/2018.
Contact Information 1800 310 300 - Technical Support Centre