The investigation determined that lower than expected vitros potassium (k+) results were obtained from a single level of vitros performance verifier (pv) ii, lot p9966, tested on a vitros 4600 chemistry system.The assignable cause of the event is unknown.Historical qc for vitros k+ lot 4102-1101-0943 leading up to the lower than expected results was acceptable, showing that this lot was performing within expectation.Additionally, repeat results from samples from a previous college of american pathologists (cap) survey were acceptable when run using vitros k+ lot 4102-1101-0943, further indicating that the reagent lot was functioning as expected and did not likely contribute to the event.Diagnostic precision testing performed using vitros na+, vitros k+ and vitros alkp was within ortho acceptable guidelines, indicating that the analyzer was operating as expected at the time of the precision testing.However, as no precision testing was performed at the time of the event, a transient instrument issue cannot be ruled out as a potential contributor to the event.Continual tracking and trending does not indicate a systemic issue with vitros k+ lot 4102-1101-0943.
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A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros potassium (k+) results were obtained from a single level of vitros performance verifier (pv) ii, lot p9966, tested on a vitros 4600 chemistry system.Vitros k+ pvii lot p9966 results of 3.46 and 3.74 mmol/l versus the baseline mean result of 5.707 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 lower than expected results were obtained from a non-patient quality control fluid.There was no 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) and reportability assessment b4.
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