A customer in united states notified biomérieux of out-of-range high benzylpenicillin results for enterococcus faecalis atcc® 29212¿ when performing internal quality control testing with the etest® benzylpenicil pg 32 us f100 (ref 502658, lot 1007341070).The customer obtained a mic of 32 mg/l (resistant) and the expected range for enterococcus faecalis atcc® 29212¿ is 1 - 4 mg/l (susceptible).As the customer was performing internal qc testing, there is no patient involved.A biomérieux internal investigation will be initiated.
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This report was initially submitted following notification from a customer in the united states regarding out-of-range high benzylpenicillin results for enterococcus faecalis atcc® 29212¿ when performing internal quality control testing with the etest® benzylpenicil pg 32 us f100 (ref 502658, lot 1007341070).Multiple quality control strains tested on the retained samples of the impacted etest pg 32 lot complied with specifications; however, out-of-range high results were observed for enterococcus faecalis atcc 29212 depending on the mueller hinton medium supplier used.Per the package insert, a quality control test must be performed to validate the quality of the medium in use.The trend analysis for the complaint topic does not show any deviation on the product reference etest benzylpenicillin pg 32 us f100 (reference 502658).Since 2010, four (4) other complaints have been registered for out of range results on etest pg 32 with enterococcus faecalis atcc 29212.These complaints were isolated events solved without investigations.As the investigation did not identify any product performance issue, neither corrective nor preventive actions will be implemented.Complaint trend analysis for the referenced product will continue to be monitored.
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