A customer in (b)(6) notified biomérieux of the misidentification of a probioqual external quality control sample, 17ca2a, when testing with vitek® 2 anc test kit (ref 21347).The expected identification is corynebacterium urealyticum.The customer stated they tested twice with vitek 2.They initially obtained a result of "unidentified organism," and the second result was 99% clostridium group.There is no indication or report from the laboratory that the discrepant quality result led to any adverse event related to any patient's state of health.There was no patient associated with this quality control sample.A biomérieux internal investigation has been initiated.
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This report was initially submitted following notification by a customer in (b)(6) of the misidentification of a probioqual external quality control sample, 17ca2a, when testing with vitek® 2 anc test kit (ref 21347).The expected identification was corynebacterium urealyticum.The customer stated they tested twice with vitek 2.They initially obtained a result of "unidentified organism," and the second result was 99% clostridium group.Biomérieux internal investigation was conducted using the strain submitted by the customer.Two (2) types of colonies were observed: - colony a (small colonies and thin growth) - colony b (large colonies) investigational testing included: - vitek ms: colony a obtained identification to corynebacterium urealyticum (99.9%) : intended result.Colony b obtained identification to staphylococcus saprophyticus (99.9%) : likely a contaminant - vitek 2 anc id (customer lot 2440318203 and random lot 2440320203) performed only on colony a: obtained excellent identification to corynebacterium urealyticum for both anc id card lots.The customer misidentification to clostridium group was not reproduced.The investigation concluded the vitek 2 anc id card is performing as intended.
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