RAPIDPoint 400/405/500 Systems and RAPIDLab 1240/1245/1260/1265 Systems (blood gas analysers). An in vitro diagnostic medical device (IVD). 의 리콜

Recall

RC-2016-RN-01098-1

Class II

2016-08-22

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01098-1

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.

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.