The investigation determined that a non-reproducible, lower than expected vitros glucose (glu) result was obtained from a single patient sample on a vitros 5600 integrated system.The most likely assignable cause for this event could not be determined.Based on historic quality control results, there was no indication that vitros glu slide lot 0023-3233-9086 malfunctioned.Based on acceptable quality control results and patient sample within-run precision testing, there was no indication the vitros 5600 integrated system malfunctioned.However, since no diagnostic precision testing was performed, an instrument related issue cannot be entirely ruled out as contributing to the event.Improper pre-analytical sample processing cannot be ruled out as contributing to the event.The sample was not centrifuged according to the sample collection device manufacturer¿s specifications, and it is likely that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.
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