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.Issue description: a customer in (b)(6) notified biomérieux of candida albicans no growth in association with chromid candida 20 plates (ref.43631, lot 1009069930, expiration date 01-mar-2022).The types of samples tested were mainly sputum, genital smears.It was reported that for several months the client has noticed that candida do not grow well on chromid candida agar.The customer has performed a sabouraud agar in parallel and there he quickly had large colonies while on the can 2 at 48 hours there were very small colonies.The customer has confirmed the identification with maldi-tof.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.
Additional Manufacturer Narrative
A customer in switzerland notified biomérieux of candida albicans no growth in association with chromid candida 20 plates (ref.43631, lot 1009069930, expiration date 01-mar-2022).The types of samples tested were mainly sputum, genital smears.Investigation: batch record review: lot# 1009069930 (ref.43631) was manufactured on the 17 and the 18-november-2021 on line auto 5 from 15h57 to 06h35.(b)(4) kits of (b)(4) plates were released with an expiry date of 01-march-2022.The production records for the lot showed it complied with specifications for all the quality controls tested.Neither non-conformances nor deviations were detected on this lot.Retained sample tests: retained sample plates of the impacted lot (1009069930) and a reference lot (1009081680) were tested with the following atcc strains: candida albicans atcc® 2091¿, atcc® 10231¿, candida tropicalis atcc® 9968¿, candida kefyr atcc® 1162¿, proteus mirabilis atcc® 12453¿ and enterococcus faecalis atcc® 29212¿.All results for the strains were in agreement with biomérieux specifications, and the customer lot was consistent with the reference lot.The retained sample plates of the impacted lot (1009069930) and the reference lot (1009081680) were tested with the six returned patient strains.Identification of the six strains were confirmed by maldi-tof method as being candida albicans.All the results of the six strains are in agreement with biomérieux specifications for the impacted lot and equivalent to the reference lot after incubation between 48-72 hours at a temperature of 33-37°c.The customer¿s issue was not reproduced with atcc strains nor with the six customer strains.Complaint database review: on the (b)(6) 2022, a search of the complaints database found no other complaints were registered on the impacted lot number (1009069930).Conclusion: the root cause of this issue remains unknown.The investigation was unable to reproduce the reported problem with atcc samples or the samples submitted by the customer.Nor was the investigation able to identify deviations in the product from our expected specifications.

• 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: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 13343334
• Report Number: 9615755-2022-00008
• Device Sequence Number: 4165088
• Product Code: JSI
• UDI-Device Identifier: 03573026118969
• UDI-Public: 03573026118969
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 03/02/2022

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: 03/01/2022
• Device Catalogue Number: 43631
• Device Lot Number: 1009069930
• 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: 12/28/2021
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown