The investigation determined that lower than expected vitros ckmb results were obtained from vitros performance verifier quality control fluids run on a vitros 250 chemistry system.User error due to improper vitros qc fluid and ckmb slide cartridge handling were the likely contributing factors to this event.Qc fluid handling & storage was a contributor to this issue as the customer uses the qc fluids until the bottle is empty instead of following the vitros isoenzyme pv instructions for use that states the qc fluid is stable for 5 days when stored at 2-8c.The vitros ckmb assay is sensitive to slide cartridge storage and handling.The customer stores the vtros ckmb slides frozen, load for a calibration event and then refreeze until the slide lot put into use.In addition, once the slide cartridge is placed on the analyzer it is used until cartridge inventory is depleted, which could go beyond 1 week.Per the vitros ckmb instructions for use, the slide cartridge unopened is to be stored frozen.Once opened it is stable for = 1 week on the analyzer.Therefore, pre-analytical slide cartridge handling is a contributor to the event.An issue with ckmb lot#: 4948-0234-5974 cannot be ruled out as a potential contributor to the event.However, ongoing tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros ckmb lot#: 4948-0234-5974.An instrument related issue cannot be completely ruled out as no diagnostic within-run precision testing was performed to assess the performance of the vitros 250 chemistry system.(b)(6).
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The customer reported lower than expected vitros ckmb results were obtained from vitros performance verifier quality control (qc) fluids run on a vitros 250 chemistry system.Vitros pvi lot f7683 = 9.3, 9.0, 9.6, 10.0, 10.4, 9.2, 9.6, 8.9, 10.2, 9.5, 9.7, 10.3 versus expected 16.7.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 on quality control fluids.There were no reports of erroneous patient results obtained, or reported from the laboratory.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number: (b)(4).
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