The investigation determined that reproducible, lower than expected ft4 results were obtained when a non-vitros audit microcontrol linearity fluid was processed using vitros ft4 lot 5430 on a vitros xt 7600 integrated system.A definitive cause of the event was not established.A vitros ft4 lot 5430 reagent issue is an unlikely cause of the event as historical qcs leading up to the event indicated acceptable vitros ft4 lot 5430 reagent performance.Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ft4 lot 5430.There was no evidence of an instrument malfunction and the vitros ft4 results for all five of the linearity fluids were reproducible on the instrument.However, as no diagnostic precision testing was conducted around the time of the event, an issue with the vitros xt 7600 integrated system cannot be completely ruled out as a contributor to the event.Improper handling of the lb linearity fluid cannot be ruled out as a contributor to the event as no information was provided when requested in relation to the pre-analytical handling of the lb audit microcontrol.
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A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report reproducible, lower than expected ft4 results were obtained when a non-vitros audit microcontrol linearity fluid was processed using vitros ft4 lot 5430 on a vitros xt 7600 integrated system.Audit microcontrol (lot 06997) lb fluid results of 2.00, 2.02 and 2.11 ng/dl verus the peer mean result of 2.75 ng/dl 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 vitros ft4 results were obtained when the customer was processing a non-patient fluid and were not reported from the laboratory.There has been no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).
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