MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID MRSA 20 PLT

Catalog Number 43451

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

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 ireland notified biomérieux of false negative result in association with chromid mrsa 20 plt ((b)(4), lot 1010111990, exp.Date: 11-sep-2023).Customer reported that he missed an mrsa strain due to it growing yellow on chromid mrsa agar.Results are summarized below: result on mrsa plate: negative the chromid mrsa result was reported as negative.There was no clinical impact.The isolate was identified as staph aureus on the vitek ms and was cefoxitin resistant by both the vitek 2 and disc diffusion.At the time of the global assessment, 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.An investigation has been initiated.

Manufacturer Narrative

Context: ********* a customer in ireland notified biomérieux of false negative result in association with chromid mrsa 20 plt (ref.(b)(4), lot 1010111990, exp.Date: 11-sep-2023).Customer reported that he missed an mrsa strain due to it growing yellow on chromid mrsa agar.Results are sumarized below: result on mrsa plate: negative the chromid mrsa result was reported as negative.There was no clinical impact.The isolate was identified as staph.Aureus on the vitek ms and was cefoxitin resistant by both the vitek 2 and disc diffusion.** batch history record and complaint trend analysis** there is no capa related to the customer¿s complaint recorded.A complaint history review was completed for this issue concluded with no implication of a trend.This complaint has not been identified as a systemic quality issue.Investigation: ************** 1.Lot number record analysis lot number 1010111990, reference 43451, was manufactured on the 26-june-2023 from 16h52 to 21h31.1412 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 lot 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 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.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 colour 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 colour.

• Brand Name: CHROMID MRSA 20 PLT
• Type of Device: CHROMID MRSA 20 PLT
• Manufacturer (Section D): BIOMÉRIEUX SA; 5 rue des aqueducs; craponne 69290 ; FR 69290
• Manufacturer (Section G): BIOMÉRIEUX SA; 5 rue des aqueducs; craponne 69290 ; FR 69290
• Manufacturer Contact: céline lacroix gimon ; 5 rue des aqueducs; craponne, MO 69290 ; FR 69290
• MDR Report Key: 17823583
• MDR Text Key: 324325424
• Report Number: 9615755-2023-00004
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2023
• Device Catalogue Number: 43451
• Device Lot Number: 1010111990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1