A customer obtained lower than expected vitros myoglobin quality control results using a non-vitros quality control fluid in combination with two different reagent lots on two different vitros 5600 integrated systems.Vitros myoglobin reagent lot 1365: cliniqa lot 1804042 l1 results of 54.5, 54.5, 53.9, 54.3, 53.1, 54.5, 52.9, 53.9, 53.3, 53.2, 53.0, 53.8, 53.8, 54.8, 55.0, 53.5, 55.0, 53.5, 53.4, 53.5, 53.7, 54.1, 54.2, 53.4, 52.6, 52.5, 53.7, 51.4, 52.2, 52.6, 51.9, 51.5, 52.5, 52.7, 54.3, 54.6, 53.6, 50.8, 51.1, 51.6, 51.0, 51.0, 51.4, 51.8, 51.0, 51.1, 52.0, 52.1, 52.8, 52.6, 52.4, 51.5, 52.6, 50.3, 51.0, 52.2, 51.4, 50.1, 52.1, 52.1, 50.6, 50.7, 50.9, 50.7, 51.2, 51.0, 51.4, 49.9, 50.6, 51.1, 51.2, 50.3, and 50.5 ng/ml vs.The expected result of 65.1 ng/ml.Vitros myoglobin reagent lot 1375: cliniqa lot 1804042 l1 results of 53.6, 54.3, 53.4, 51.6, 51.6, 51.1, 51.4, 50.6, 51.8, 50.0, 50.7, 50.3, 50.6, 49.9, 50.5, 50.4, 50.6, 51.6, 52.7, 52.1, 53.0, 51.6, 51.6, 52.5, 52.6, 53.4, 53.7, 53.1, 53.5, 52.8, 53.1, 53.3, 54.2, and 53.0 ng/ml vs.The expected result of 65.1 ng/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The lower than expected vitros myoglobin results were generated from a non-patient fluid, however the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.Ortho has not been made aware of allegation of actual patient harm as a result of the event.This report is number one of four mdr¿s for this event.Four 3500a forms are being submitted for this event as four devices were involved.(b)(4).
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