MAUDE Adverse Event Report: BIOMERIEUX S.A. CHROMID® SALMONELLA AGAR

Catalog Number 43621

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) notified biomérieux of obtaining false negative results when testing with the chromid® salmonella (20 plates) agar (ref.43621, lot 1007376340).The customer reported growth of uncharacteristic white colonies on the agar.No pale pink colonies were noted.The customer was performing confirmatory testing with a powder sample collected from soil and equipment at a dairy site.There is no patient associated with the tested sample.There is no adverse event related to any patient's state of health due to these discrepant results.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was initiated following notification from a customer in france of obtaining false negative results when testing salmonella enterica ser.Bonn with the chromid® salmonella (sm2) agar (ref.43621, lot 1007376340).The customer reported growth of uncharacteristic white colonies on the agar.No pale pink colonies were noted.1.Lot number record analysis: lot number 1007376340 was manufactured on 29-may-2019.All expected quality control tests (macroscopic appearance, ph measures and microbiological performances) were carried out prior to its release with no observed performance issue (sensibility and/or specificity) in the medium.The recovery rate for all positive controls were within qc specifications.2.Retained sample analysis: the investigation included testing of retained samples of the impacted lot as well as parallel testing of other lots of chromid sm2 agar at different ages from manufacturing date.The lot numbers tested were as follow: a fresh lot number just manufactured : 1007552790 expired date:15/01/2020.2 weeks after manufacturing : 1007519360 expired date: 25/dec/2019.4 weeks after manufacturing: 1007471080 expired date: 29/nov/2019.7 weeks after manufacturing: 1007415660 expired date: 04/nov/2019.A lot number with a similar expiration date as the impacted lot: 1007491870 expired date:02/oct/2019.Fertility performance of these six lots were evaluated by using five species of salmonella spp strains coming from biomérieux internal collection.These included strains of salmonella typhimurium atcc 14028, salmonella paratyphi a atcc 9150 , salmonella enteriditis atcc 13076 and salmonella paratyphi b atcc 10719 , as well as the strain of salmonella enterica ser.Bonn submitted by the customer.All of them were inoculated following the routine protocol described in the quality control methodology; after incubation at 33-37°c and examined for growth after 24h and 48h on the six lots tested, the following results were obtained: whatever the batch of the medium tested, all atcc strains produced the expected colony appearance, developing as spontaneous pink to mauve after 24 hours or 48 hours of incubation.Field food strain of salmonella enterica ser.Bonn : after 24 hours of incubation, testing gave a negative color reaction, producing colorless colonies.After 48 hours of incubation, testing produced some colonies with a weak mauve coloration with a white background.According to the packet insert, the industry application of this medium is expecting growth at 24 hours; therefore, the investigation confirmed the customer's false negative results with this strain after 24 hours at 33-37°c.This result for the submitted strain was reproduced on all lots tested.The fact that all lots detect esterase activity for atcc strains shows there is not any issue with chromogenic mixture, and the product performed the same as at the time was released.Performance of the media are similar whatever the batch of the medium tested.Because of confirmation of this negative result at 24 hours, the investigation was extended to a total of 56 salmonella strains by the r&d team with the goal to confirm if product performs within specifications obtained at the time it was launched.First, the customer strain ( salmonella enterica ser.Bonn ) was tested on chromid salmonella media (ref 43621), asap (ref aeb 52009) and salma (ref 418246) plate.The strain was correctly detected after 24h on asap and salma media but only after 48h on chromid salmonella medium.This assay proves the c8 esterase activity of the customer's strain.The following strains have been tested: submitted customer strain ( salmonella enterica ser.Bonn ).Set of 15 strains selected from internal strain collection tested by the rdcs team.Extended set of 40 salmonella strains tested by culture media support team.For an industry application and after 24 hours of incubation, among the 56 strains tested on the medium, 51 were correctly detected on chromid sm2, giving a detection sensitivity of 91.07% with interval confidence [80.74 ; 96.13].These results are statistically different from the performances mentioned in the ifu (97.5% [86.84-99.94]), but the ifu references a study done on clinical samples (not direct strains testing) and the panel of salmonella serotypes tested was more narrow.The choice of serotypes used for a validation has a strong impact on performances.Rdcs team results remain acceptable (>90%) and comparable to the performances obtained during the verification of the chromid sm2 (during verification before launch).In consequence chromid salmonella remains conform to our performances criteria obtained by r&d prior to launch despite results obtained with customer strain.3.Complaint trend analysis.A review of complaints for the impacted lot (1007376340) since its release indicates that no other complaints were registered for this type of issue.Moreover, statistical trend analysis was performed for this product reference considering data from january 2015 regarding false negative issues with no indication of any systemic issue and/or safety risk necessitating the implementation of actions on this product reference.Based on this analysis,the investigation concludes that the product meets its specifications.4.Conclusion the lot number record analysis indicates that the impacted lot ( 1007376340 ) complies with specifications and neither non-conformances nor deviations were recorded.In addition, no other complaints were registered on this lot number.The quality control tests performed during the investigation did not highlight a deviation in the quality of the product.Because customer results were confirmed with the customer's salmonella enterica ser.Bonn strain, a study was extended by r&d with a total of 56 salmonella strains.The result of this study confirms that sensitivity remains acceptable ( > 90 % ) and comparable to the performances obtained during the initial verification of chromid sm2.Although the issue was confirmed only at 24 hours of incubation, the investigation concluded that the customer issue is within product limitation: depending on the specimens analyzed and the microorganisms being tested for: clinical use: it is recommended to use this medium in conjunction with additional media.Industry use : chrom id salmonella is not validated as a unique media for alternative detection method of salmonella.In the context of en iso 6579-1 standard specifications, isolation on chromid salmonella agar should be performed in parallel to additional xld media (giving characteristic colonies with salmonella enterica ser.Bonn.When chromid salmonella is used as a confirmation test for presumptive positive results obtained with another method, in case of discordant results (between alternative method and confirmation test), the laboratory must take the necessary steps to ensure that results obtained are accurate.Based on all above elements about performances and based on the different ways chromid salmonella is used for industry applications, the risk of false negative result is considered as minor.As the performance of the lot number tested is within specifications, neither corrective nor preventive actions will be implemented.

• Brand Name: CHROMID® SALMONELLA AGAR
• Type of Device: CHROMID® SALMONELLA AGAR
• Manufacturer (Section D): BIOMERIEUX S.A.; 5 rue des aqueducs; craponne, 69290 ; FR 69290
• MDR Report Key: 9452061
• MDR Text Key: 219214191
• Report Number: 9615755-2019-00020
• Device Sequence Number: 1
• Product Code: JSI
• UDI-Device Identifier: 03573026118877
• UDI-Public: 03573026118877
• Combination Product (y/n): N
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2019
• Device Catalogue Number: 43621
• Device Lot Number: 1007376340
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1