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 Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in the (b)(6)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.The customer stated that no incorrect result was reported to the treating physician, and that no patient harm or inappropriate treatment occurred.The customer indicated a delay of >24 hours to report a result due to additional testing required.The customer informed biomérieux that the chromid candida plates are routinely left in the lab on a rack for about five (5) hours during the day and the leftover plates are returned to the refrigerator.Per the chromid candida agar (can2) instructions for use.This medium must not be exposed to light other than during the inoculation and reading steps.Allow reagents to come to room temperature in the dark.Inoculate the specimen.Immediately incubate the inverted plates in the dark at +37°c in aerobic conditions.The user is responsible for choosing the appropriate incubation temperature for the intended use, in accordance with current standards.The cultures are generally examined after 24, 48 hours of incubation, or even 72 hours depending on the type of specimen and the kind of microorganism being detected.The customer stated that, in spite of this instruction, the candida albicans ncpf 3255 growth control passed each day.The customer stated that the reported patient results were not affected by this issue.However the customer reported a delay of >24 hours between the time when the initial results should have been reported and the time when the repeat result was reported.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: 8375662
• MDR Text Key: 141220380
• Report Number: 9615755-2019-00002
• 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: 02/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2019
• Device Catalogue Number: 43631
• Device Lot Number: 1006898250
• 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