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
Product description: 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.Complaint description: a customer in spain complained after observing absence of growth when using chromid candida 20 plates (ref (b)(4), lot 1010039600).The customer said that they had inoculted vaginal samples onto chocolate agar plates and that after incubation they had obseved a microbial growth.The customer states that the same samples were inoculated onto chromid candida plates and that after incubation no yeast growth was obtained.No furhter details were provided.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.
Additional Manufacturer Narrative
Following the absence of growth reported by the customer when using chromid candida 20 plates (ref (b)(4), lot 1010039600) an investigation has been carried out at biomèrieux manufacturing site.A review of manufacturing batch record of chromid candida 20 plates ref (b)(4) lot used by the customers was performed and no non-conformance or deviations were identified.The results of all in-process and quality assurance release for sales test were found to be within specification.Retained samples of the lot 1010039600 as used by the customer were tested in parallel with a reference lot (reference (b)(4), lot 1009993690, expiry date 02-august-2023).The tests were performed using the quality control (qc) strains and in accordance with the qc protocol used for the release of each lot number.The qc results obtained for the strains tested are in accordance with the expected specifications for the impacted lot and the reference lot tested: a good growth was observed for candida kefyr 1162, candida albicans atcc 2091, atcc 10231 and candida tropicalis atcc 9968, with the development of characteristic colonies.The issue reported by the customer could not be reproduced.The review of the worldwide complaint database was performed for reference (b)(4) and lot 1010039600.No other complaints were identified for this reference number and lot number.The customer could not submit the concerned sample thus no additional investigation could be performed.In mitigation of the growth issue observed by the customer the device instruction for use reads: "growth depends on the requirements of each individual microorganism.It is therefore possible that certain yeast strains which have specific requirements (substrate, temperature, incubation conditions, etc.) may not develop or may not produce color." biomeriéux¿s investigation to date has been unable to identify a definitive root cause of the lack of growth obtained by the customer.In any case there is no evidence of any systematic failure of the biomerieux chromid candida 20 plates (ref (b)(4), lot 1010039600) to perform as intended.

• 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: stefania ciranda ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 17285883
• Report Number: 9615755-2023-00002
• Device Sequence Number: 11509391
• Product Code: JSI
• UDI-Device Identifier: 03573026118969
• UDI-Public: 03573026118969
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 08/04/2023

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: 08/28/2023
• Device Catalogue Number: 43631
• Device Lot Number: 1010039600
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/04/2023
• 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