VITROS CHEMISTRY PRODUCTS OP REAGENT 6801997

[78986228] The investigation determined that unexpected discordant vitros op negative results were obtained from samples from three separate patients which were reported as op negative when the physician expected a positive op result from all three patients when tested on a vitros 5600 integrated chemistry system. The vitros chemistry products op 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 this 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 likely cause is a known limitation of the vitros op reagent related to low cross reactivity with synthetic opioids. The customer did not send the samples for additional testing to confirm. There is no evidence to suggest that the vitros op reagent lot 1527-09-5708 malfunctioned. Although there is no indication that the instrument was not performing as intended, an instrument issue cannot be completely ruled out as a contributing factor to the event. There is no information to suggest that the vitros op reagent malfunctioned.
Patient Sequence No: 1, Text Type: N, H10

[78986229] A customer obtained unexpected discordant vitros op negative results using a <300 ng/ml cutoff from samples from three separate patients which were reported as op negative when the physician expected a positive op result from all three patients due to their condition (heroin overdose), on a vitros 5600 integrated chemistry system. Patient 1 vitros result < 100 ng/ml (negative) versus an expected positive result (>300 ng/ml). Patient 2 vitros result < 100 ng/ml (negative) versus an expected positive result (>300 ng/ml). Patient 3 vitros result < 100 ng/ml (negative) versus an expected positive result (>300 ng/ml). Biased results of the magnitude and direction observed may lead to inappropriate physician action. The discordant vitros op-lo results were reported out of the laboratory. However, there was no report of treatment started, stopped, or altered based on the false negative vitros op-lo results and there was no report of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics (ortho) inc. Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5