ADVIA Centaur and ADVIA Centaur XP 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2013/005

CON236897

2013-02-14

2013-02-14

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON236897?tabName=allTabs

A failure of the wash interconnect circuit board on the advia centaur and advia centaur xp analysers may produce the following errors: 1. failure to detect that the ‘wash 1’ bottle is empty. this could result in credible but erroneous results reported on a number of tests. see affected assays listed below. or 2. incorrect indication that the ‘wash 1’ bottle is empty when actually full, causing the system to stop processing samples. siemens is planning software and hardware updates to resolve these issues by the end of march 2013. the table below summarises the assays affected and what the potential effect is for each. assay type assay potential effect on assay results auto-immune ana false positive or negative bone vitd false positive or negative cardiovascular bnp, high bias ddimer, false positive or negative tniultra always elevated torch and special id rubg2, false positive or negative rubm, false positive or negative toxg, false positive toxm false positive reproductive endocrinology dheas, false positive or negative ee2, false positive or negative shbg false positive or negative infectious disease ahavm, false positive ahavt/havt, low bias ahbcm, false negative ahbct/hbct, false negative ahbe, high or low bias ahbs, false positive ahbs, false positive ahbs2, false positive or negative ahcv, false positive or negative chiv, false positive or negative cmvg, false positive or negative conf, false positive or negative ehiv, false positive hbeag, false positive hbs, false positive hiv, false positive or negative pct, false positive or negative syph false positive or negative immunosuppressant csa low bias liver fibrosis ha,  false positive or negative piinp, false positive or negative timp1 false positive or negative tumour markers / oncology ca153, false positive ca19-9, false positive ca199a, false positive or negative freepsa false positive or negative thyroid tsh3ul false positive or negative.

Identify if you have affected devices. Follow the manufacturer’s recommendations in the FSN to: Monitor ‘Wash 1’ fluid levels manually. Replace the ‘Wash 1’ bottle before the fluid is depleted. Clear incorrect status or error messages that prohibit testing. Contrary to the manufacturer’s FSN, consider the need to review previous results.