The investigation confirmed that a lower than expected vitros myoglobin (myog) result was obtained from a cliniqa quality control (qc) fluid processed using vitros myog reagent in combination with a vitros 5600 integrated system.The investigation was unable to determine a definitive assignable cause.However, a possible cause for the lower than expected qc fluid result is a suboptimal calibration event.Qc performance improved after another calibration event was executed.In addition, per a customer communication issued 28 november 2018, calibrators must be left out for a minimum of two hours following reconstitution prior to calibrating.Because the customer could not confirm this protocol was initially followed, pre-analytical fluid handling cannot be ruled out as a cause of this event.The vitros 5600 integrated system was performing as intended and did not likely contribute to the event as within-run precision testing performed by the customer was within acceptable guidelines.Additionally, a reagent issue is not a likely cause of the event as a different vitros 5600 integrated system is running as expected when using the same vitros myog reagent lot.Furthermore, continual tracking and trending of complaints has not identified any signals that show a potential systemic issue with vitros myog reagent lot 1390.
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