The investigation determined that non-reproducible, higher than expected vitros sodium (na+) results were obtained from a non-vitros biorad quality control (qc) fluid processed using vitros chemistry products na+ slides lot 4232-1043-4495 on a vitros 5600 integrated system.Biorad lot 56950 level 1 results of >250 and >250 mmol/l vs an expected result of 121.6 mmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The non-reproducible, higher than expected results were from a qc fluid and were not reported outside of the laboratory.However, the investigation was unable to confirm that patient sample results were not or would not be affected if the event were to recur undetected.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number two of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).
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The investigation determined that non-reproducible, higher than expected vitros sodium (na+) results were obtained from a non-vitros biorad quality control (qc) fluid processed using vitros chemistry products na+ slides lot 4232-1043-4495 on a vitros 5600 integrated system.The investigation could not determine a definitive assignable cause of the event.Based on historical quality control results, a vitros na+ lot 4232-1043-4495 performance issue is not a likely contributor to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros na+ lot 4232-1043-4495.A slide cartridge related issue could not be confirmed nor entirely ruled out as contributor of the event.However, it is not a likely cause as the non-reproducible, higher than expected results were obtained from two different slide cartridges.In addition, acceptable results were obtained upon repeat testing from the same slide cartridge in each event.An instrument related issue is not a likely contributor of the event as diagnostic precision testing performed on the vitros 5600 integrated system was within ortho acceptable guidelines.(b)(4).
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