An internal biomérieux investigation was performed with results as follows: the biomérieux internal cap d-10 strain was rehydrated and subcultured under anaerobic conditions.Testing included individual organism suspensions on anc cards from four different lots, in duplicate, and the vitek® ms.Exper/essay 5491/108 the eight (8) anc cards tested resulted in low discrimination identifications of multiple clostridium species, not the expected result.Testing with the vitek® ms resulted in the expected identification of p.Granulosum with a 99.5%confidence value.Review of the customers p.Anaerobius results against expected reactions for p.Granulosum demonstrated six atypical negative reactions (ellm, pyra, arg, pvate, amani, drib) and atypical positive morphology (gpc) according to the anc knowledge base and contributing to the misidentification.The customer reports a result of unidentified when entering morphology as gpr but this lab report was not saved for submittal.An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain.Quality system review of the most recent quarterly trend report, 2017 q2, did not identify this complaint as a systemic quality issue.This is an atypical strain.
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