According to the complaint received, an intensive care unit reported discrepant na+ results on an abl90 flex plus analyzer for multiple patient results measured (b)(6) 2019 despite of approved controls.A number of samples were measured on two abl90 flex analyzers (1 and 2), see the measurements in the table below: (b)(6).Based on the measurements above the abl90 flex analyzer 2 demonstrated increased measurement results compared to comparison measurements performed on the other abl90 flex analyzer 1.All checks performed in this period on both analyzers were ok.The solution pack on the abl90 flex analyzer 2 was consequently replaced, which stabilized the measurements on the abl90 flex analyzer 2 again.The customer complaints that the abl90 flex analyzer 2 provided false high na+ results while the controls were approved.
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