ONLINE TDM Gentamicin assay 에 대한 현장 안전성 서한

Field Safety Notice

Slovenia

AMPMDRS

In the last version of this customer letter we informed you about the implementation of an instrument factor (if) for online tdm gentamicin that was - based on available data - the mitigation for the reported issue. however, against initial data the correction of the instrument factor did not mitigate the issue. we received complaints from customers who implemented the if, observing decreased sample recovery using the online tdm gentamicin assay. since availability of fresh patient samples for gentamicin is very limited, frozen patient samples had to be used for internal investigations. obviously, the internal results obtained with these samples and used for the implementation of the if did not match with the external observations reported by customers. further investigations were initiated at roche to understand this mismatch. in order to verify the internal results a new panel of patient samples was collected (panel b, stored at -80°c) and compared to the panel that was used for the determination of the if (panel a, stored at -20°c). .