The investigation determined that discordant, higher than expected ckmb results were obtained from a single patient sample when processed using vitros ckmb slides lot 4948-0234-6019 on a vitros 5600 integrated system.A definitive cause of the event was not established with the information provided.A vitros ckmb lot 4948-0234-6019 slide issue cannot be ruled out as a contributor to the event, as quality control results around the time of the event showed inaccuracy but other vitros ckmb results between lots showed concordance with other patient samples.Ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ckmb lot 4948-0234-6019.An instrument issue cannot be ruled out as a contributor to the event, as no diagnostic precision test was carried out to verify instrument performance when requested.In addition, pre-analytical sample processing could not be ruled out as a contributing factor as it could not be determined whether the customer was following the sample collection device manufacture¿s recommendation for sample centrifugation.Improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.
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