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Intended use: chromid¿ mrsa agar is a chromogenic medium for the screening of methicillin-resistant s.Aureus (mrsa) in chronic carriers or patients who are at risk for mrsa.This medium does not replace conventional antimicrobial susceptibility tests.Mrsa are multi-resistant bacteria which may cause nosocomial infections.The detection of mrsa carriers is particularly important for the epidemiological prevention and monitoring of these infections.In this context, the use of chromid¿ mrsa agar contributes towards the active surveillance of mrsa.Issue description: a customer in the netherlands notified biomérieux of a dark yellow colony coloring for an mrsa strain associated with chromid mrsa 20 plt - ref.(b)(4), lot 1010111990.The customer uses the inoculation after enrichment method and reported that the isolate had a dark yellow color by 24 hours that became more pronounced by 48 hours.Biomérieux gcs (global customer support) indicated that the coloration is due to the alpha-glucosidase activity of mrsa strains and that it is possible that this strain does not have this enzymatic activity, and would result in the colonies not growing with the expected green color.There is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.
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Biomerieux received two complaints about mrsa isolates that grew with dark yellow color instead of green color on chromid¿ mrsa agar (mrsa) reference (b)(4), lot 1010111990.Two strains were submitted, and photos were provided.Biomérieux performed an investigation.1.Lot number record analysis lot number 1010111990, reference (b)(4), was manufactured on the (b)(6) 2023 from 16h52 to 21h31.1,412 kits of 20 plates were released with an expiry date of 11-september-2023.The quality control of the weight and appearance of the product was performed for the duration of the manufacturing process.The results complied with specifications.All the controls performed in order to release the product complied with specifications, in particular the microbiology activity tests.Non-conformances and deviations linked to a performance issue were not detected on this batch.2.Retained sample analysis biomérieux retains samples of every lot number released to the market.As the impacted lot 1010111990 was expired at the time of the investigation, tests were performed on retained samples from other lots of chromid® mrsa agar manufactured with the same dehydrated formulation, and at different stages of their shelf life.The plates from retained samples were inoculated with the strains used for the release of the lots.For fertility performance, all results are within specification for all lots tested, in particular, staphylococcus aureus atcc® 43300¿ showed a good growth with the typical green colonies.For selectivity performance, all the routine negative strains from our internal collection are totally inhibited for all the plates from the lots tested.To summarize, all results concerning fertility (numeration, colony size and enzymatic activity) and selectivity were as the ones expected for all the lots tested and within our performance criteria specifications.3.Returned strains analysis the two returned strains were tested with plates from the same lots of retained samples.The strains were inoculated following the routine protocol described in the quality control methodology.Following incubation at 33-37°c, growth was examined after 18 hours and extended if necessary up to 48 hours in case of colourless colonies.The two strains returned were also identified using vitek 2 system, and an antibiogram was performed.After 18 -24 hours of incubation, the two returned clinical strains grew perfectly but colourless, whatever the lot tested.After 48 hours one of the strains produced a slight low green colour only in the confluent area, whereas for isolated colonies the absence of the colour was well maintained whatever the lot tested.The second strain remained colourless after 48 hours of incubation.According to these results we can conclude that: - customer results have been reproduced on the plates from the retained samples of the five different lots tested.- these results are reproduced in all lots tested, so we can discard a punctual issue of the lot number complained.The problem is not lot or product related but seems to be related to the returned clinical strains characteristics.Oxacillin screening test was performed with the vitek 2 system: both clinical strains are oxacillin resistant and mec a+.Biochemical vitek 2 identification was realized for the 2 strains returned.The result obtained in both cases is: staphylococcus aureus with an excellent interval of confidence detection (98 % and 99 % respectively).Both strains are -glu negative: they are not expressing the -glucosidase activity pathway and so do not have the enzymatic activity to develop the typical green colour.Therefore, with these results, we can conclude to an atypical enzymatic pattern for these two mrsa clinical strains.4.Complaint trend analysis on the (b)(6) 2023, complaint trending was performed on the impacted lot number 1010111990.Apart from these two complaints, no other complaint was registered on this lot.5.Final conclusion the lot number record analysis indicated that the impacted lot complied with our specifications and neither non-conformances nor deviations were recorded at the release of the lot.The quality control tests performed on several lot numbers during the investigation did not identify a performance issue for the reference (b)(4).The two returned clinical strains showed good growth in all lot tested after 24h of incubation, without the green color expected for the colonies after 48 h of incubation.A biochemical identification and an antibiogram were performed, confirming that the two strains are mrsa mec a +, but without -glucosidase activity.These particular strains do not likely hydrolyse the glucosidase substrate giving rise to spontaneous green color.As chromid¿ mrsa agar (mrsa) reference (b)(4) is performing within specifications and the issue observed is linked to atypical clinical strains characteristics, neither corrective nor preventive actions will be implemented.
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Intended use: chromid¿ mrsa agar is a chromogenic medium for the screening of methicillin-resistant s.Aureus (mrsa) in chronic carriers or patients who are at risk for mrsa.This medium does not replace conventional antimicrobial susceptibility tests.Mrsa are multi-resistant bacteria which may cause nosocomial infections.The detection of mrsa carriers is particularly important for the epidemiological prevention and monitoring of these infections.In this context, the use of chromid¿ mrsa agar contributes towards the active surveillance of mrsa.Issue description: a customer in the netherlands notified biomérieux of a dark yellow colony coloring for an mrsa strain associated with chromid mrsa 20 plt - ref.(b)(4), lot 1010111990.The customer uses the "inoculation after enrichment" method and reported that the isolate had a dark yellow color by 24 hours that became more pronounced by 48 hours.Biomérieux gcs (global customer support) indicated that the coloration is due to the alpha-glucosidase activity of mrsa strains and that it is possible that this strain does not have this enzymatic activity, and would result in the colonies not growing with the expected green color.There is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.
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