The investigation determined that higher than expected vitros tsh results were obtained from non-vitros biorad control fluids processed using vitros tsh reagent lot 6480 on a vitros 5600 integrated system.The investigation was unable to determine the assignable cause of the event.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros tsh reagent lot 6480.Based on the historical tsh quality control performance, a vitros tsh reagent issue was not a likely contributing factor to this event.The biorad qc results were unacceptable for multiple analytes and not isolated to only tsh.Therefore, an issue with the sample handling, storage or preparation of the biorad fluids could not be confirmed or ruled out as a potential contributing factor to the event.The customer processed a vitros tsh marker precision, as well as an additional precision testing using the non-vitros biorad control fluids, both of which were within ortho acceptable guidelines.There is no indication that the vitros 5600 integrated system or the vitros tsh reagent malfunctioned.Email address for contact office is (b)(4).
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The investigation determined that higher than expected vitros tsh results were obtained from non-vitros biorad control fluids processed using vitros tsh reagent lot 6480 on a vitros 5600 integrated system.Biorad immunoassay plus control lot 85220 results 37.65, 38.81 miu/l vs an expected result of 26.0 miu/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The higher than expected vitros tsh results were obtained from non-patient fluids.However, the investigation cannot conclude that patient sample results were not affected and could not be affected if the event were to recur undetected.Ortho has not been made aware of any allegation of patient harm as a result of these events.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 number (b)(4).
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