T2 biosystems' distributor (italy) relayed a customer complaint that the t2bacteria panel resulted in a positive p.Aeruginosa result on a clinical sample using t2dx instrument isa3317000134.The customer reported that this was a false positive outcome as compared to a hemoculture positive for streptococcus parasanguinis, which is not detected by the t2bacteria panel.Patient details were not provided.Based on the information provided by the distributor, there was no allegation from the institution that the alleged false positive led to an adverse event or patient harm.The t2bacteria panel and associated blood samples were discarded after use.Review of the design history records of the associated t2bacteria lot (wo-20570) resulted in no findings related to product quality.Fse observation of the customer's sample preparation methods suggested procedures that deviated from the ifu.T2 biosystems service advised on best practices for sample handling and instrument maintenance according to the ifu and operator manual.
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