The investigation determined that a discordant, negative vitros benz result was obtained from a single patient sample using the vitros 5600 integrated system, when compared to a positive result obtained using two different non-vitros methods.The compound detected by the non-vitros methods was temazepam glucuronide.The intended use section of the vitros benz ifu states that the vitros chemistry product benz assay is intended for use by professional laboratory personnel.It provides only a preliminary test result.A more specific alternative chemical method must be used to confirm a result obtained with the vitros benz assay.Gas chromatography/mass spectrometry (gc/ms) is the preferred confirmatory method.Clinical consideration and professional judgment should be applied to any drug-of-abuse test result.The most likely cause is a known limitation of the vitros benz reagent related to low cross reactivity with temazepam glucuronide.There is no evidence that a reagent related issue contributed to the event.
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A customer obtained a discordant, negative vitros benz result for single patient sample run on the vitros 5600 integrated system when compared to a positive result obtained using two different non-vitros methods.Patient result of <85 ng/ml vs.An expected result of 2977 ng/ml.Biased patient results of the direction and magnitude observed could lead to inappropriate physician action.The discordant, negative result was not reported out of the laboratory and there was no report of patient harm as a result of this event.(b)(4).
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