MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID SALMONELLA ELIT 20 PLT

Catalog Number	412108
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® salmonella elite agar is a chromogenic medium for the selective isolation and identification of salmonella in human specimens (stools).Issue description: a customer in spain notified biomérieux of no growth with a salmonella strain in association with chromid salmonella elit 20 plt (ref.412108, lot unknown).The customer stated that with salmonella chromogenic plates they do not detect some strains because they do not change the color.They have checked with maldi-tof and the strains are salmonella but the chromid medium has not detected them.There is no delay in diagnosis because they use other means in parallel.At the time of 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 spain notified biomérieux of no growth with a salmonella strain in association with chromid salmonella elit 20 plt (ref.412108, lot unknown).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: since the impacted lot was expired at the time of the investigation and the patient strains were not available, it was not possible to perform an extended investigation.1.Lot number record analysis.The lot number 1010504550, reference (b)(4), was manufactured on the 02-february-2024 from 04h08 to 10h28.2269 kits of (b)(4) plates were released with an expiry date 27-april-2024.In order to release the product, technical laboratory quality controls 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.Non-conformances and deviations were not registered during the manufacturing process and at release of this lot.2.Retained samples analysis.Biomérieux retains sample plates of every lot number released to the market.It was not possible to investigate the retained samples plates for the impacted lot number 1010504550 as the lot number had expired at the time of the investigation conclusion: the lot number record analysis indicated that the impacted lot number 1010504550, reference (b)(4), complied with biomérieux specifications and neither non-conformances nor deviations were recorded on this lot during the manufacturing process and at release.The complaint review indicates that no other complaint was registered against lot number 1010504550 for growth issue.

• Brand Name: CHROMID SALMONELLA ELIT 20 PLT
• Common Device Name: CHROMID SALMONELLA ELIT 20 PLT
• Manufacturer (Section D): BIOMÉRIEUX SA; 5 rue des aqueducs; craponne 69290 ; FR 69290
• Manufacturer (Section G): BIOMÉRIEUX SA; 5 rue des aqueducs; craponne 69290 ; FR 69290
• Manufacturer Contact: céline lacroix gimon ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 19172914
• Report Number: 9615755-2024-00001
• Device Sequence Number: 7873880
• Product Code: JSI
• UDI-Device Identifier: 03573026374846
• UDI-Public: 03573026374846
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: 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): 05/23/2024

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: 04/27/2024
• Device Catalogue Number: 412108
• Device Lot Number: 1010504550
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 05/23/2024
• 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