The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range and no instrument errors occurred at the time of the event.A siemens customer service engineer (cse) was dispatched to the customer site.The cse checked instrument temperatures, which were in range.The cse also ran a precision study for prothrombin time, which recovered acceptably.Qc was run after the service visit and recovered in range.Inadequate mixing, centrifugation or other mishandling of the sample cannot be excluded contributing factors to the event.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.
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A discordant, falsely elevated prothrombin time (pt) result and a discordant, falsely elevated prothrombin time international normalized ratio (inr) result were obtained on a patient sample on a sysmex ca-660 system using dade innovin reagent.The discordant results were reported to the physician(s) and were questioned.Prior to obtaining the discordant results, the patient sample was run for pt and inr, generating a "no coagulation" error and no numeric results.After the physician(s) questioned the results, the patient was redrawn, and the redrawn sample was run for pt and inr, recovering lower.The first sample was then repeated for pt and inr, also recovering lower.Both the first sample and the redrawn sample were then run for pt and inr on an alternate sysmex ca-660 system, also recovering lower.The pt inr results obtained from the redrawn sample on the alternate sysmex ca-660 system were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated pt and inr results.
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