AQURE Data Management System, Version 1.54. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2013-RN-01318-1

Class I

2013-12-13

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01318-1

Results which are repressed on the analyser are shown in aqure version 1.5.4 and forwarded to the his/lis. repression means that values flagged with errors (marked with "?") are not displayed on the analyser. the repressed results are forwarded to aqure and flagged, but dependant on the settings of the hospital it, the result may not be flagged in his/lis. the problem is present when the user has enabled the option 'repress results' on the analyser and uses aqure version 1.5.4.The results may not be flagged in his/lis and the user will therefore not be aware that the result may be incorrect. patient treatment or diagnosis could therefore be based on an incorrect result.An example:the abl90 analyser did not give a cl- result due to the error 1227 "correction for bicarbonate contains errors from ph, pco2". however the chloride result was displayed in the following way:on the analyser: blank (no value) and "?"aqure: 100mmol/l with "?" and highlighted redhis/lis: 100mmol/l.

Radiometer is configuring the database of the AQURE system to ensure that all "?" marked results are blanked in AQURE and prior to transmitting to the HIS/LIS. Radiometer recommends a review of previous patient results with repressed parameter values in AQURE and HIS/LIS.