The investigation determined that non-reactive vitros anti-sars-cov-2 total (cov2tot) results were obtained from a single patient sample processed using vitros cov2tot lot 0021 on a vitros 5600 integrated system.A definitive assignable cause for the discordant non-reactive results could not be determined with the information provided.Based on historical quality control results, a vitros cov2tot reagent performance issue is not a likely contributor to the event as all vitros quality control (qc) fluid results were within the correct ifu interpretation region.Additionally, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros cov2tot lot 0021.There is also no indication of an instrument malfunction and unexpected instrument performance is not a likely contributor to the event.However, it cannot be entirely ruled out as a contributing factor as precision testing to assess instrument performance was not performed by the customer.In addition, it was established the customer is following the sample collection device manufacturer¿s recommended centrifugation protocol; therefore, pre-analytical sample processing can be ruled out as a contributing factor.A definitive cause of the event was not determined.
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A customer obtained discordant, non-reactive vitros anti-sars-cov-2 total (cov2tot) results from a single patient sample processed using vitros cov2tot lot 0021 on a vitros 5600 integrated system.Patient 1 results of 0.53, 0.58 and 0.80 s/c (non-reactive) versus the expected result of reactive.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The vitros cov2tot results were not reported from the laboratory to a physician and were not used to aid in diagnosis of sars-cov-2 infection.Patient management was not influenced based on the vitros results and ortho is not aware of any allegation of actual patient harm as a result of this event.This report is number two of three mdr¿s for this event.Three 3500a forms are being submitted for this event as a total of three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4).
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