The investigation determined that lower than expected vitros ckmb results were obtained when testing a single level of an unknown quality control fluid on a vitros 350 chemistry system.The definitive assignable cause of the lower than expected vitros ckmb results could not be determined.The control fluid the customer is using for routine vitros ckmb quality control testing was not provided; therefore it was not possible to verify performance for both accuracy and precision.In addition, no information was provided concerning the customer's fluid handling protocols.Therefore, it is possible the affected results are due to a pre-analytical sample handling issue, but this could not be confirmed with the information provided.Diagnostic within run precision testing was not performed to evaluate the vitros 350 system performance.Therefore an unexpected analyzer issue or an issue with vitros ckmb cannot be ruled out as contributing to the event.
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The customer observed negatively biased quality control results processed using vitros ckmb slides on a vitros 350 chemistry system.Biased results of the direction and magnitude observed may lead to inappropriate physician action if patient samples were affected.There was no report of patient harm as a result of this event.Unknown quality control fluid, vitros ckmb results 7.6 and 14.7 u/l versus the calculated mean 23.6 u/l.This report is number one of two 3500a forms filed for this event, as two devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).
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