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

Catalog Number 43631

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of obtaining irregular growth of candida albicans when testing clinical samples with the chromid® candida agar plate (ref.43631, lot 1007462580).The customer reported that the growth of candida albicans was normal on blood agar as compared to "no", "scanty", and "irregular shaped" colonies on the candida agar.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

A customer in hong kong 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
• Type of Device: CHROMID® CANDIDA AGAR
• Manufacturer (Section D): BIOMERIEUX S.A.; 5 rue des aqueducs; craponne, 69290 ; FR 69290
• MDR Report Key: 9428401
• MDR Text Key: 219210984
• Report Number: 9615755-2019-00018
• Device Sequence Number: 1
• Product Code: JSJ
• UDI-Device Identifier: 03573026118969
• UDI-Public: 03573026118969
• Combination Product (y/n): N
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2019
• Device Catalogue Number: 43631
• Device Lot Number: 1007462580
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1