MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID® CANDIDA

Catalog Number	43631
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Intended use: chromogenic medium for the selective isolation of yeasts and the direct identification of candida albicans.This medium is a medium for: the selective isolation of yeasts, the identification of the species c.Albicans, the presumptive differentiation of a group of species comprising c.Tropicalis, c.Lusitaniae and c.Kefyr.Description: a customer in france notified biomérieux of observing no growth for candida albicans on chromid candida 20 plates (ref 43631, lot 1009083210).The customer reported that candida albicans grows very little or not at all on chromid candida 20 plates (ref 43631, lot 1009083210) while the organisms grow well on pvx or anc agars.The customer also performed testing of a candida albicans atcc strain in parallel with two different lots of chromid candida (lot 1009083210 and lot 1009159280).The results showed growth on lot 1009159280 while there was no growth on lot 1009083210.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.
Additional Manufacturer Narrative
An investigation was initiated in response to a customer complaint of observing no growth for candida albicans on chromid candida 20 plates (ref 43631, lot 1009083210).Investigation: complaint trend analysis: global customer service (gcs) performed a complaint trend analysis and did not identify this issue as a trend for the chromid candida agar.Manufacturing record review: chromid candida (ref 43631, lot 1009083210) was manufactured on the 23 november 2021.(b)(4) were released with an expiry date of 07-mar-2022.The quality control of the weight and appearance of the product was performed for the duration of the manufacturing process.The results comply with our specifications for the impacted lot.In order to release the product, technical laboratory quality controls were performed on retained samples, in particular microbiological activity controls.All the results are in agreement with specifications for microbiological activity for all the quality control strains tested: good growth of characteristic colonies for candida albicans atcc 2091, candida albicans atcc 10231, candida tropicalis atcc 9968 and candida kefyr 1162 after 24 hours and 48 hours of incubation.Total inhibition of proteus mirabilis atcc 12453 and enterococcus faecalis atcc 29212 after 48 hours of incubation.The impacted lot number 1009083210 complied with specifications for all the quality controls tested.Neither non conformances nor deviations were detected on the lot 1009083210.Retained sample analysis: biomérieux retains samples of every lot number released to the market.The retained sample plates of the impacted lot 1009083210 and a reference lot 1009237340 were tested with the following atcc strains: candida albicans atcc 2091, atcc 10231, candida tropicalis atcc 9968, candida kefyr 1162, proteus mirabilis atcc 12453 and enterococcus faecalis atcc29212.All the results for all the strains are in agreement with our specifications for the impacted lot and equivalent to the reference lot.The growth issue was not reproduced with the retained samples of the impacted lot.Returned plates analysis: one kit of 20 plates, reference 43631, of the impacted lot number 1009083210 was provided by the customer for the investigation.The plates of this returned kit and plates from the reference lot 1009237340 were tested with the following atcc strains: candida albicans atcc 2091, atcc 10231, candida tropicalis atcc 9968, candida kefyr 1162, proteus mirabilis atcc 12453 and enterococcus faecalis atcc29212.All the results for all the strains are in agreement with our specifications for the impacted lot and equivalent to the reference lot after incubation of 48 hours at a temperature of 33-37°c.The growth issue was not reproduced with the returned plates of the impacted lot.Root cause: the cause of the customer's issue could not be determined.The growth issue experienced by the customer was not reproduced during any investigational testing.Conclusion: the cause of the customer's issue could not be determined.The growth issue experienced by the customer was not reproduced during any investigational testing.Global customer service (gcs) performed a complaint trend analysis and did not identify this issue as a trend for the chromid candida agar.The manufacturing record review indicated that the impacted lot 1009083210 complied with all specifications.This product must not be exposed to light other than during the inoculation and reading steps, the package insert states "if the instructions for use are not complied with (exposure to light), a lack of color for yeast colonies, or even inhibited growth of certain strains may be observed." in addition, in case of no growth after 24 hours, the incubation of the plates chromid® candida agar (can2), reference 43631 can be extended until 72 hours as indicated in the package insert.

• Brand Name: CHROMID® CANDIDA
• Common Device Name: CHROMID® CANDIDA
• 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: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 13725562
• Report Number: 9615755-2022-00009
• Device Sequence Number: 20347452
• Product Code: JSI
• UDI-Device Identifier: 03573026118969
• UDI-Public: 03573026118969
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2022
• Device Catalogue Number: 43631
• Device Lot Number: 1009083210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown