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

Catalog Number	43631
Medical Device Problem Codes	False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from (b)(6) notified biomérieux of not obtaining growth for a patient candida albicans isolate from a vaginal swab plated onto chromid® candida 20 plates media (reference 43631, lot 1007462580).The customer confirmed the patient sample was plated onto columbia (cos) media in parallel with the chromid candida media, lot 1007462580.The isolate was also repeated on chromid candida media using lot 1007582260.Both the cos media and chromid candida media lot 1007582260 were positive for growth of candida.The customer confirmed the discrepant result had no adverse effect to the patient's state of health.Biomérieux will initiate an internal investigation.
Additional Manufacturer Narrative
A customer in italy notified biomérieux of obtaining irregular growth of candida albicans when testing clinical samples with the chromid® candida agar plate (ref.43631, lot 1007462580).In response to the customer complaint biomérieux conducted an internal investigation, which included testing of retained agar, analysis of returned agar, and a review of production records.Note: the customer did not submit the impacted strain for investigation therefore confirmatory testing of the isolate could not be performed.The following results were obtained: the retains of lots 1007462580 and 1007562620 were tested with atcc® organisms including candida albicans; all results were within specification one kit of returned plates was also tested for all quality control strains including candida albicans atcc® 2091 and candida alibicans atcc® 10231; all organisms tested obtained in-specification results.Review of the manufacturing batch records indicated that the impacted lot complied with specifications and neither non-conformances nor deviations were recorded.The error obtained by the customer was not reproduced.The chromid® candida agar plate package insert states: "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." therefore, it is possible the impacted strain has specific growth requirements.However, as the impacted strains were not available for the investigation, it was not possible to verify this hypothesis.The investigation concluded chromid® candida agar plate lot 1007462580 is performing within specifications.

• 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: 9288346
• Report Number: 9615755-2019-00013
• Device Sequence Number: 11374708
• Product Code: JSJ
• UDI-Device Identifier: 03573026118969
• UDI-Public: 03573026118969
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 02/19/2020

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: 10/21/2019
• Device Catalogue Number: 43631
• Device Lot Number: 1007462580
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1