A customer in (b)(6) notified biomérieux of a false negative result associated with bact/alert® 3d instrument.The customer reported the blood culture bottles were incubated in the instrument for three (3) days.If the result is positive, they subculture and continue the testing to identify the organism and the antibiotic sensitivity.If the result is negative, the customer incubates the negative bottle in the normal incubator (37c) for 24 hours and then subculture it.The organism was identified as pseudomanas aeruginosa.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.An internal biomérieux investigation will be initiated.
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An internal biomérieux investigation was performed with results as follows: the customer reported a false negative result for the bact/alert® 3d 60 instrument for bact/alert® fa plus clinical blood culture bottles.However, it was determined the customer did not follow the p/n 410851 bact/alert® fa plus bottle ifu [9312050 e -2016-04] that recommends an incubation time period of five (5) days.The customer incubated the bottles for less than the recommended five (5) days.Incubating for less than the recommended time may not be enough time for the instrument to flag a bottle positive if low numbers of organism are present in the sample, or if the sample contains inhibitory factors that can slow microbial growth [antibiotics, immune substances, etc.] the customer has been notified and is aware of the recommended five (5) day bottle incubation time frame per the bact/alert® fa plus bottle ifu.The customer has agreed to change their laboratory procedure and follow the bottle ifu direction to incubate bottles on the instrument for five (5) days or until designated positive.There was no harm reported for the patient.Due to the nature of the incident, the complaint is coded as a false negative-operator error because the customer was not following the bact/alert® fa plus bottle ifu.The bact/alert® 3d 60 instrument backup or bottle graphs were never received from the customer, therefore, biomérieux cannot further investigate the issue.
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