MAUDE Adverse Event Report: BIOMÉRIEUX, SA CHROMID® CPS® ELITE

Catalog Number	418284
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Intended use: chromid® cps® elite agar is an isolation, enumeration and identification medium for urine specimens.It enables: the microbial enumeration of the specimen by means of standardized inoculation methods.The direct identification of escherichia coli and the presumptive identification of the following bacterial species or genera : enterococcus, klebsiella, enterobacter, serratia, citrobacter (kesc), proteus, providencia, morganella (proteeae).Issue description: a customer in (b)(6) notified biomérieux of false negative result (no growth) with fungi strain from patient urine sample in association with chromid cps elite 20 plt trans (ref.(b)(4), lot 1009788140, exp date.4/25/2023) the customer stated that he had discrepant results between: the culture on chrom id cpse and the chemical-physical examination of the urine samples collection for an urine culture sample.Result summary: the culture on chrom id cpse plate: no growth; chemical-physical examination : presence of fungi.The conditions of conservation and use of the media have been adequately respected from the customer.Until now , the customer has not used sabouraud gentamicin chloramphenicol in parallel of chrom id cpse, but she will do when the chemical-physical examination reveals the presence of fungi.The customer informed biomérieux customer service that no delay in the results occurred because the customer immediately reported the presence of fungi to the clinician.Biomérieux customer service informed the customer that ¿according to the package insert, ¿growth depends on the requirements of each individual microorganism.It is therefore possible that certain strains which have specific requirements (substrate, temperature, incubation conditions, etc.) may not develop¿.¿ at the time of the global assessment, there is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.An investigation will be initiated.
Additional Manufacturer Narrative
Context: ********* a customer in italy notified biomérieux of false negative result (no growth) with fungi strain from patient urine sample in association with chromid cps elite opaque 20 pt (ref.(b)(4), lot 1009788140, exp date.4/25/2023) investigation: *************** ** batch history record and complaint trend analysis** there is no capa related to the customer¿s complaint recorded.A complaint history review was completed for this issue concluded with no implication of a trend.This complaint has not been identified as a systemic quality issue.**investigation results** 1.Batch record analysis lot number 1009788140, reference (b)(4), was manufactured on the 28-december-2022 from 06h01 to 16h46.3726 kits of 20 plates were released with an expiry date of 25-april-2023.All the manufacturing data was reviewed such as, preparation of the media, filling step, weight / appearance quality controls and all the parameters were within specifications.There were no non conformities linked with manufacturing and/or any type of observation that could explain the reported issue.In order to release the product, technical laboratory quality controls (qc) were performed on samples that were manufactured at different manufacturing times.The samples were tested for the product's appearance, ph, microbiology state and microbiological activity.All the controls performed complied with specifications.Neither non-conformances nor deviations were detected on lot 1009788140 at product release.2.Retained samples analysis biomérieux retains samples of every lot number released to the market.Retained sample plates from the impacted lot were tested according to the quality control protocol used for the release of the lot.After 18-24h of incubation at 33-37°c we did not observe any performance issue (sensitivity and/or specificity).The recovery rate for all positive controls was within qc specifications: - escherichia coli atcc® 25922: good growth with burgundy colonies - escherichia coli 9909604 ( - gur negative): good growth with beige-pink colonies - proteus mirabilis atcc® 12453: good growth with beige colonies and brown halo - enterococcus faecalis atcc® 29212: good growth with turquoise colonies - streptococcus agalactiae atcc® 12386: good growth with blue-violet colonies - staphylococcus aureus atcc® 25923: good growth with colorless colonies, meaning ¿no green or pink color¿ - klebsiella pneumoniae atcc® 13883: good growth with blue-green colonies a panel of eight candida strains were tested on the impacted lot along with five different lots of chromid cpse, manufactured on different dates in order to verify: - if the problem observed by the customer could be reproduced on another lot.- product reproducibility by performing comparative tests.- the stability of the product.All the lots tested detected a good recovery of growth with the development of characteristic colonies for candida albicans atcc 10231, candida albicans atcc 2091, candida albicans atcc 90028, candida albicans atcc 60193, candida parapsilosis atcc 22019, candida krusei atcc 6258, candida tropicalis atcc 9968 and candida metapsilosis atcc 10232.The reported issue was not reproduced, whatever the species of candida tested, and the lot tested.Conclusion: ************* the lot number record analysis indicated that the impacted lot, 1009788140, complied with biomérieux specifications and non-conformances were not recorded during the manufacturing process.Retained sample plates from the impacted lot number were tested in accordance with the quality control protocol to release the lots.All the results were within specifications.Eight additional candida strains were added to the panel of tests and were also within specifications.The reported issue, namely, no growth of yeasts on cpse, was not reproduced during this investigation with the impacted lot number 1009788140.

• Brand Name: CHROMID® CPS® ELITE
• Common Device Name: CHROMID® CPS® ELITE
• Manufacturer (Section D): BIOMÉRIEUX, SA; 6, c de isaac newton; tres cantos; madrid 28760 ; SP 28760
• Manufacturer (Section G): BIOMÉRIEUX, SA; 6, c de isaac newton; tres cantos; madrid 28760 ; SP 28760
• Manufacturer Contact: céline lacroix gimon ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 16528777
• Report Number: 3009307598-2023-00001
• Device Sequence Number: 20145278
• Product Code: JXA
• UDI-Device Identifier: 03573026468828
• UDI-Public: 03573026468828
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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: 04/25/2023
• Device Catalogue Number: 418284
• Device Lot Number: 1009788140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown