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A customer in (b)(6) notified biomérieux of reagent (b)(6) results for (b)(6) atcc® 6538¿ while performing quality control (qc) testing with bact/alert® sa bottles (ref.259789, lot 0001055384).Lot 0001055384 was inoculated with (b)(6) atcc® 6538¿ and (b)(6) aureus atcc® 25923¿.The customer stated (b)(6) results were obtained for the bottles inoculated with (b)(6) atcc® 25923¿; however, bottles with (b)(6) atcc® 6538¿ obtained (b)(6) results.Additionally, the customer also tested (b)(6) atcc® 6538¿ using the bact/alert fa plus culture bottle and obtained (b)(6) results.Biomerieux customer service requested the customers back up data as well as details regarding the customer¿s sample preparation and handling techniques.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated.
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A customer in germany notified biomérieux of reagent false negative results for staphylococcus aureus atcc® 6538¿ while performing quality control (qc) testing with bact/alert® sa bottles (ref.259789, lot 0001055384).Two additional similar complaints were recorded for two other bact/alert sa bottle lots.Therefore the scope of the associated investigation ((b)(6)) is for the following bact/alert culture bottles that experienced growth failure of s.Aureus with atcc® 6538¿ and/or atcc® 25923¿ strains during a seeded study for qualification of a new bact/alert culture bottle lot: ¿ case (b)(6): bact/alert sa (p/n 259789) lot 0001055230 with an expiry date of 10feb2021; ¿ case (b)(6): bact/alert sa (p/n 259789) lot 0001054432 with an expiry date of 23sep2020; ¿ case (b)(6): bact/alert sa (p/n 259789) lot 0001055384 with an expiry date of 11mar2021.None of the three lot numbers above had any other false negative or seeded study complaints.Impact:230 and sa lot 0001054432 with atcc 6538 during new lot qualification testing.Bact/alert culture b the customer reported no growth of staphylococcus aureus (s.Aureus) with bact/alert sa lot 0001055ottles were parallel tested with becton-dickinson (bd) bottles and the bd bottles showed growth.Testing with atcc 25923 s.Aureus also failed to show growth with sa bact/alert culture bottles.Retain testing: this study evaluated growth performance of two american type culture collection (atcc) strains of s.Aureus (atcc 6538 and atcc 25923) to determine if the results observed at the customer sites were test-event related or a result of low inoculation concentration.Two target inoculum concentrations were tested during this study: 10-20 cfu/bottle and 80-100 cfu/bottle.The outcome of this in-house study indicated that all bottles resulted in positive results in <51 hours to detection regardless of strain type, inoculation target, or incubation temperature (32.5°c vs 37°c).The in-house test results were significantly different from the results obtained by the customer.The customer-reported false negative (no growth) results at 120 hours.The in-house study did not confirm this issue reported by the customer.It was recommended that further investigation be conducted at the customer¿s site to identify test-related factors that may have resulted in false negative bact/alert culture bottles.Investigation: root cause analysis and conclusion: based on the evaluation of data and limited information provided by the customer, there were two ¿most probable¿ root causes for no organism growth (s.Aureus) in bact/alert sa bottles pertaining to complaint (b)(4): 1) materials/storage.The customer notified biomérieux that during qualification of a new sa lot 0001055230 with atcc 6538 (s.Aureus) during a seeded study testing, the bottles failed to grow the organism.In addition, the sa lot 0001054432 (lot nearing expiration) did not grow s.Aureus either.Bottles from the sa lot 0001055230 did show growth with bacillus subtilis and aspergillus organisms.The sa bottles were inoculated in parallel with bottles from bd and the bd bottles showed growth; therefore the bact/alert sa bottles were considered ¿false negative¿ by the customer.The seeded study testing scenarios pertaining to different sa lots with different atcc strains by the customer did not provide adequate information or clarity for the sequence of events.New lot 0001055230 (expiry 10feb2021) failed growth with atcc 6538 and atcc 25923.The bottles showed no growth in the media or growth in a graph (atcc 6538) and customer stopped further testing with this lot.Lot 0001054432 (expiry 23sep2020) failed growth with atcc 6538; however, flagged positive in repeat testing.Lot 0001055384 (expiry 11mar2021) failed growth with atcc 6538 and had positive growth with atcc 25923.After repeat testing, this lot showed positive growth with a new atcc 6538 strain.It is recommended by clsi/nccls document m22-a3 (section 5.5.3) and cumitech 31a (quality control of organisms) that organisms to be used for quality control be prepared on a yearly basis and stored frozen.It was noted that the source of the customer¿s atcc strains were from (b)(6) institute where microorganisms/cell cultures are collected, investigated and archived.The (b)(6) strains were obtained by the customer in 2018 and stored at -80°c.An older stock strain (older than one year) could have compromised growth performance and not perform as well for all media types.When the customer tested sa lot 0001055384 with a new atcc 6538, there was positive growth within an acceptable number of days (1.69 days / approximately 40.6 hours).2) technique the customer is provided with adequate references in the ifu and the bact/alert user manual that address how to perform a seeded study for qualification of a bact/alert culture bottle lot as part of the customer¿s quality control, if needed.At the time of this complaint ((b)(4)), csn 2696 - seeded blood culture study protocol for the evaluation of the bact/alert microbial detection system (p/n 60-00799-2/october 2015) would have been available to the customer.Csn 2696 outlined a seeded study process specifically using biomérieux culture bottles.It also noted variables in user technique that could potentially inhibit organism growth in a culture bottle [e.G.How stock cultures are maintained, proper angle of puncture into the bottle, gauge size of the needle, or timeliness of inoculation into a bottle with aerobic organisms (within 60 minutes of making the suspension)].It is unclear whether the customer followed csn 2696 or conducted their seeded study independent of biomérieux recommendations.The customer stated that the organism suspensions for their study and inoculum were used to inoculate bact/alert sa culture bottles as well as bd culture bottles.Growth of s.Aureus was evident in the bd bottles and growth was also evident in bact/alert sa culture bottles intermittently depending on different sequences of sa lot, atcc strains, and repeat testing.If the customer did not adhere to how stock cultures should be maintained, proper angle of puncture into the bottle, gauge size of the needle, or timeliness of inoculation into a bottle with aerobic organisms (within 60 minutes of making the suspension), then growth performance of organisms (e.G.S.Aureus) in sa bact/alert culture bottles could be inhibited.Device history record and complaint trends: queries of manufacturing data and review of manufacturing records for the bact/alert sa lots did not reveal any adverse trends relating to growth performance (¿no growth¿ with s.Aureus atcc strain) issues.Queries on complaint data showed no adverse trend is present for the error code false negative-subculture negative ¿ c912 or false negative-c502 for clinical blood culture bottles.Conclude product compliance to specification/performance: there is no evidence of any bottle malfunction with the bact/alert sa culture bottle lots.Monitoring and detection methods for potential bottle contamination are part of the manufacturing and quality control processes for bact/alert culture bottles.
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