[60441490]
A customer in france reported a misidentification result for a urine sample from yersinia media in association with the vitek 2 gram-negative (gn) id test kit. Providencia rettgeri was identified as yersinia pestis. The customer queried the identification and sent the strain to an external laboratory for result confirmation. The external laboratory used the bruker ms methodology and reported a providencia rettgeri. The customer isolated the strain on cos media and tested again using the vitek 2 gn test kit, and it again identified yersinia pestis. The test reports were requested from the customer. In addition, we requested isolate submittal as well. An internal biom? Rieux investigation has been initiated. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. An internal biom? Rieux investigation has been completed. The customer reported testing the urine isolate at 24 hrs from yersinia medium and the two more times when isolated from columbia blood agar (cba). - results from yersinia agar show 2 atypical negative reactions (ure,ellm) for providencia rettgeria according to the gn knowledge base. - the first test from cba showed 3 atypical negative reactions (larl, ure, ellm) for providencia rettgeria according to the gn knowledge base. - the second test from cba showed 4 atypical negative reactions (larl, dman, ure,ellm) for providencia rettgeria according to the gn knowledge base. An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain. Without the strain or raw data it's not possible to further evaluate the cause of the misidentification or to determine which identification (gn vs bruker ms) is correct. It should be noted that yersinia medium is not recommended for use with the gn card. Review of the manufacture of gn lot 241379410 confirmed that the lot met final qc release criteria and there were no issues observed during initial qc performance testing. The biom? Rieux investigation concluded the that the vitek 2 gram-negative (gn) id test kit performed according to product specification.
Patient Sequence No: 1, Text Type: D, B5