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

Catalog Number 43631

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in the (b)(6) reported a false negative result for a patient sample from a genital swab, on chromid® candida (can2) (lot 1006823440).The sample was positive on microscopic examination for yeast cells, but the culture was negative on can2 plates after 48 hours incubation.The microscopy examination and culture on can2 were repeated, along with culture on sabc (sabouraud dextrose agar chloramphenicol - oxoid) media.The microscopy was still positive for yeast cells.The sabc showed heavy growth of candida sp.One blue colony was present on the can2 plate, after 48 hours incubation.Additional testing was performed with can2 plates already in use, and can2 plates that were taken from boxes in the cold room of the same lot.The culture was also repeated with sabc plates.The repeat culture demonstrated a heavy growth of candida sp.On the sabc plates.The customer obtained just one blue colony on the can2 plate in use and no growth on the newer can2 plate.The two blue colonies were isolated on two different can2 plates were confirmed as candida sp.By performing a wet preparation and the observation of yeast cells.The customer stated that the patient results were not affected by this issue as they reported the result from the sabc plate.However the customer reported a delay of 48 hours between the time when the initial results should have been reported on (b)(6) 2018 and the time when the repeat result was reported on (b)(6) 2019.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in the united kingdom contacted biomérieux to report the occurrence of little/no growth (false negative) for a candida albicans strain in association with the chromid® candida media.The patient isolate was confirmed as candida albicans via maldi-tof test method.Biomérieux investigation was conducted.The following tests were performed: identification of the strains by vitek® ms.Microbiological activity on chromid candida plates for the submitted strains along with a quality control strain (candida albicans atcc 10231).The following results were obtained: the identification of candida albicans was confirmed by vitek ms.Weak growth with no coloration was observed after 24h of incubation at 33-37°c.After 48h, good growth of blue characteristic colonies for candida albicans was observed.For the quality control strain, the results obtained were all within specifications.The issue observed by the customer, no growth on chromid candida reference 43631, was not reproduced.Review of the manufacturing batch records indicated that the impacted lot complied with specifications and neither non-conformances nor deviations were recorded.The customer had specified that the chromid candida plates are routinely left in the laboratory on a rack for approximately five (5) hours (light exposure) during the day and the leftover plates may then be returned to the refrigerator.This prolonged exposure of the product to light could explain the results obtained.The package insert states "this medium 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." the investigation concluded the performance of the chromid® candida agar is 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: 8318908
• MDR Text Key: 138520560
• Report Number: 9615755-2019-00001
• 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: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2019
• Device Catalogue Number: 43631
• Device Lot Number: 1006823440
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1