The investigation determined that higher than expected vitros anti-hbs (ahbs) results were obtained from different samples from the same patient processed using vitros ahbs reagent lot 3270, and lot 3280 on a vitros 3600 immunodiagnostic system.The most likely cause of this event is due to a non-specific antibody interference present in the patient sample.The testing of the patient sample treated with the non-specific antibody blocking tube (nabt) tube supports this, as it shows a large decrease in sample reactivity compared to the original untreated sample result.
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A customer obtained higher than expected vitros anti-hbs (ahbs) results from different samples from the same patient processed using vitros ahbs reagent lot 3270 and lot 3280 on a vitros 3600 immunodiagnostic system.14 feb 2019- patient 1, sample 1 vitros ahbs positive result of 31.2 miu/ml versus expected <8.0 miu/ml (negative).19 mar 2019- patient 1, sample 2 vitros ahbs positive result of 113 miu/ml versus expected <8.0 miu/ml (negative).April 2019- patient 1, sample 3 vitros ahbs positive result of >100 miu/ml versus expected <8.0 miu/ml (negative).Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The higher than expected vitros ahbs results were reported from the laboratory but were questioned by the physician.There was no change in treatment, and ortho has not been made aware of any allegation of actual patient harm as a result of the event.This report is number two of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers: (b)(4).
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