A customer in the united states contacted biomérieux to report a misidentification of cap survey organism pediococcus acidilactici as pediococcus pentosaceus in association with the vitek® 2 gram-positive (gp) identification (id) test kit.Repeat testing provided the same result.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to any patient's state of health.There was no patient directly associated with the cap survey sample.Culture submittal was requested by biomérieux for internal investigation.This event has been reviewed for vigilance reporting in accordance with 21 cfr 803, concerning medical device reporting.Biomérieux internal (b)(4), rev.02.A, sec.4.2.3.6 states erroneous test results / incorrect id results could have a negative impact on treatment and potentially lead to unnecessary treatment.This review has determined that this event meets the criteria for reporting.Although this event does not allege that death or serious injury actually occurred, it has been determined that there is potential for serious injury should the situation recur while testing a patient isolate.There is no field safety corrective action associated with this event.Biomérieux investigation was initiated.
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