A customer contacted the ortho clinical diagnostics (ortho) technical service center (tsc) to report non-reproducible, higher and lower quality control results were obtained using non-tsc biorad quality control fluid with the current, in-use tsc phyt slide lot on a tsc xt7600 integrated system.Tsc biorad l3 results of 33.9, 32.7, 26.8, 26.5, 15.8, 16.1, 16.5, 16.4, 14.9, 25.9, 15.2, 16.7 and 16.8 ug/ml vs.The expected result of 26.26 ug/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number eleven of thirteen mdr¿s for this event.Thirteen 3500a forms are being submitted for this event as thirteen devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).
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The investigation determined that higher and lower than expected vitros phyt quality control results were obtained from a single level of non-vitros biorad lot 85260 controls using vitros phyt slide lot 2621-0180-9363 on a vitros xt7600 integrated system.The definitive cause of the event could not be determined with the information provided.Historic quality control results using vitros phyt slide lot 2621-0180-9363 was not acceptable for within-lab precision.In addition, diagnostic within-run precision testing using vitros phyt slide lot 2621-0180-9363 was not performed on the vitros xt7600 integrated system, therefore, a vitros xt7600 system or vitros phyt slide lot 2621-0180-9363 performance issue cannot be ruled out as contributing to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros phyt slide lot 2621-0180-9363.Email address for contact office above is (b)(6).
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