The investigation determined that higher than expected vitros tsh results were predicted from two samples from a single patient processed on a vitros eci immunodiagnostic system when compared to the tsh result obtained from a non-vitros method.A definitive assignable cause could not be identified.Based on historical qc data, a reagent performance issue could not be ruled out as a contributing factor.No instrument issue was identified as a contributing factor, however; a within-run precision test that would verify the performance of the vitros eci instrument was not processed, therefore, an instrument related issue cannot be entirely ruled out.Information regarding pre-analytical sample handling was not provided and therefore inappropriate sample preparation also cannot be ruled out as a contributing factor.
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