A customer reported quality control results are out of range when using etest cefepime pm strips, (b)(4), lot 1003907350.Customer has conducted 3 quality control test with, e.Coli 25922, staphylococcus aureus 29213 and pseudomonas aeruginosa 27853 in duplicate using new strips.One out of two strips for e.Coli and staphylococcus aureus/carbapenemase-producing enterobacteriaceae were out of range.Both strips for pseudomonas aeruginosa were in range.Additional testing has been performed but results are consistently high (0.064).
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Biomérieux internal investigation was conducted.The customer lots of etest® cefepime were tested with six (6) internal atcc® tm strains.- atcc® 27853 tm pseudomonas aeruginosa (range 1-4 g/ml) - results obtained: 1.5 g/ml (passed).- atcc® 29212 tm enterococcus faecalis (range 6-64 g/ml) - results obtained: 12 or 16 g/ml (passed).- atcc® 49247 tm haemophilus influenzae (range 0.5-2 g/ml) - results obtained: 1 or 1.5 g/ml (passed).- atcc® 49619 tm streptococcus pneumoniae (range 0.064-0.25 g/ml) - results obtained: 0.125 g/ml (passed).- atcc® 29213 tm staphylococcus aureus (range 1-4 g/ml) - results obtained: 3 g/ml (passed) the investigation, following the ifu recommendations, did not reproduce the customer result (6 g/ml / result out of range).- atcc® 25922 tm escherichia coli (range 0.016- 0.125 g/ml) - results obtained: 0.047 or 0.064 g/ml (passed).The investigation, the ifu recommendations, did not reproduce the customer result (0.064 or 0.125 g/ml).The investigation concluded the etest® cefepime product is performing in accordance with specifications.Furthermore, follow-up with the customer indicates the etest cefepime is now passing qc after incorporating a different growth media with the proper agar characteristics.
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