The customer reported lower than expected vitros ckmb quality control results were obtained on a vitros 250 chemistry system.Vitros ckmb qc result = 13.9, 13.0, 7.0 u/l vs expected result of 20.1 u/l.A biased result of the direction and magnitude observed may lead to inappropriate physician action if undetected.No patient samples were tested during this time period.There was no allegation of patient harm as a result of this event.This report is number one of three mdr¿s for this event.Three 3500a forms are being submitted for this event as three devices were involved.(b)(4).
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The investigation determined that lower than expected vitros ckmb quality control results were obtained on a vitros 250 chemistry system.After recalibrating the same vitros ckmb reagent lot, acceptable quality control performance was observed using a fresh quality control sample.The investigation concludes that the most likely cause of this event is a suboptimal calibration issue.The cause of the suboptimal calibration is unknown.An instrument issue, reagent issue or a fluid issue could not be ruled out as contributing factors.
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