The customer reported low biased prothrombin time inr (pt-inr) results on three consecutive cap surveys with the innovin reagent on the bcs xp system.When converting to a new lot of innovin reagent, the account discovered that there had been an error in the mnpt setting for the lot that had been in use.Patient pt-inr results were reported to the physicians during the period of the incorrect setting for the old lot.There is no indication that physicians questioned patient results reported with the incorrect setting in place.Calculations show that higher results would have been reported with the correct mnpt factor setting.The customer did conduct an investigation of previously reported results and some corrected reports were issued.It is unknown if patient treatment was altered or prescribed on the basis of the low biased pt-inr results.There is no report of adverse outcome to patients as a result of the low biased pt-inr results.
|