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

Catalog Number	43631
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomérieux of obtaining faint color when performing quality control testing with atcc® strains on chromid candida 20 plates (ref (b)(4), lot 1008005050).The customer reported that they observed slightly blue (almost white) colonies when growing a candida albicans atcc strain instead of blue.They also observed white colonies when growing a candida tropicalis atcc strain while they should appear pink.There is no indication or report from the customer that this lot was used by this customer to test patient samples.The complaint only indicates that testing was performed with atcc strains.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A customer in mexico notified biomérieux of obtaining faint color when performing quality control testing with atcc® strains on chromid candida 20 plates (ref 43631, lot 1008005050).The customer also observed white colonies when growing a candida tropicalis atcc strain; the expected colony color was pink.In response to the customer complaint, biomérieux conducted an internal investigation.Lot 1008005050 had already expired at the time of the investigation, therefore investigational testing could not be performed.Review of lot 1008005050 manufacturing records found no anomalies during the manufacturing of lot 1008005050.Review of quality control tests showed lot 1008005050 met specification for all quality controls tested.This included meeting specification for growth and characteristic colony color when culturing atcc® 10231¿ candida albicans, atcc® 9968¿ candida tropicalis, and atcc® 1162¿ candida kefyr after twenty four (24) and forty eight (48) hours of incubation.The investigation also noted the chromid candida 20 plates package insert states the product must not be exposed to light other than during the inoculation and reading steps.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.Refer to section h10.

• Brand Name: CHROMID CANDIDA AGAR
• Common Device Name: CHROMID® CANDIDA AGAR
• Manufacturer (Section D): BIOMERIEUX S.A.; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 10403605
• Report Number: 9615755-2020-00012
• Device Sequence Number: 19567676
• Product Code: JSJ
• UDI-Device Identifier: 03573026118969
• UDI-Public: 03573026118969
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2020

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: 07/21/2020
• Device Catalogue Number: 43631
• Device Lot Number: 1008005050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1