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

Catalog Number	43631
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from (b)(6) reported that he observed no growth during a quality control test with the qc strain candida albicans atcc 10231 on chromid® candida agar (ref.(b)(4)).The customer reported that they performed a quantitative test with 10-100 cfu candida albicans atcc 10231 on chrom-id-candida.The estimated recovery rate should be 50-200 % but they observed no growth.For detection / qualitative analysis, no issue was observed.To be noted, the qc described in the instruction for use does not include an estimated recovery rate, but a microbial activity with good growth level.Indeed, enumeration is not in the intended use of the product.The customer performs the quantitative test as a delivery control for every lot they receive.The customer stated that usually the quantitative test always showed less growth, but never no growth as it was observed this time.There is no patient involved as this event occurred during quality control and this is an industry customer.A biomérieux internal investigation has been initiated.
Additional Manufacturer Narrative
An investigation was initiated in response to a customer complaint of no growth during a quality control test with the qc strain candida albicans atcc® 10231¿ on chromid® candida agar (ref.43631, lot 1008415270).A review of production records for lot 1008415270 was performed and did not identify any issues with the manufacturing process for this lot.Additionally, quality control (qc) test results prior to release of the lot were in compliance with specifications.Complaints registered for ref 43631 and lot 1008415270 were reviewed, and this review did not identify any trends for either the product or this specific lot.The customer returned plates from lot 1008415270 for investigation testing.The customer's returned plates from lot 1008415270 were tested along with retain samples from the same lot as well as plates from a reference lot (1008431550).Investigation testing did not reproduce the customer's issue of no growth detected for candida albicans atcc® 10231¿ on any of the plates.However, the plates returned from the customer produced smaller colonies with colors that are not the expected colors for the strains tested.Retain samples of the customer's lot (1008415270) and the reference lot (1008431550) produced colonies with good growth and the expected coloration.The chromogenic substrates in the chromid candida agar are very light sensitive and their deterioration will lead to the absence of coloration of candida colonies.From the results obtained during investigation testing, the most likely cause for the smaller colonies and poor coloration has been determined to be exposure to light due to incorrect storage of the plates in the customer's laboratory after receipt, or poor shipment conditions from the customer to biomérieux during the return.

• Brand Name: CHROMID CANDIDA
• Common Device Name: CHROMID® CANDIDA
• Manufacturer (Section D): BIOMERIEUX S.A.; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 11499834
• Report Number: 9615755-2021-00005
• Device Sequence Number: 11457072
• Product Code: JSI
• UDI-Device Identifier: 03573026118969
• UDI-Public: 03573026118969
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/16/2021

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: 03/08/2021
• Device Catalogue Number: 43631
• Device Lot Number: 1008415270
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1