MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID S.AUREUS ELITE 20 PL - 419042

Catalog Number	419042
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: chromogenic medium for the selective isolation and the direct identification of s.Aureus.This chromogenic medium is intended for the selective isolation and the direct identification of s.Aureus in human specimens: in 18 to 24 hours for the following specimens: blood cultures, nasal swabs, suppurations, ear/nose/throat samples, genital samples, stool samples, skin samples from serious burn victims, respiratory samples (including respiratory samples from patients with cystic fibrosis), and up to 48 to 72 hours for respiratory samples from patients with cystic fibrosis.This medium is intended for the prevention and diagnosis of s.Aureus infections using samples of human origin.Issue description: a customer in australia notified biomérieux that they obtained false negative results for staphylococcus aureus in and possible false positive results for serratia marcescens in association with the chromid s.Aureus elite 20 pl (ref 419042, lot 1010407570).The customer reported that they observed pink colony coloration for serratia marcescens and yellow coloration for staphylococcus aureus after 48 hours of incubation.Identifications of the colonies were performed with maldi-tof.Global customer service (gcs) reviewed the troubleshooting information and photos provided by the customer.Gcs determined that the red colonies that the customer considers pink, in fact, are red colonies where the coloration is totally diffused within the agar.The ifu states that "a typical color that spreads in the agar must not be taken into account." the yellow colonies that have been identified by maldi-tof may be s.Aureus but without the enzymatic pathway involved in the chromogenic substrate.There is no indication or report from the customer that this event led to or contributed to death, serious injury, or serious deterioration in the state of health of any patient.An investigation will be initiated.
Additional Manufacturer Narrative
An investigation was initiated in response to a customer complaint of false negative results for staphylococcus aureus and possible false positive results for serratia marcescens in association with the chromid s.Aureus elite 20 pl (ref 419042, lot 1010407570).Investigation.Complaint trend analysis: global customer service (gcs) performed a complaint trend analysis and did not identify the customer's issue as a trend for chromid s.Aureus elite.Manufacturing record review: chromid s.Aureus elite (ref 419042, lot 1010407570) was manufactured on 07dec2023.840 kits of 20 plates were released with an expiration date of 25mar2024.All manufacturing data were reviewed such as, preparation of the media, filling step and weight controls and all parameters are within specifications.The process of chromid s.Aureus elite supplement preparation met specifications and the quantity of the atb chrom id s.Aureus elite supplement has been added properly.The quality control of the weight and appearance of the products were performed for the duration of the manufacturing process.The results complied with specifications.As part of product release, technical laboratory quality controls were performed on retained samples that were manufactured at different manufacturing times.The samples were tested for the product's appearance, ph, microbiology state and performance.All the controls complied with specifications.No nonconformances (ncs) or quality events (qes) were recorded for this lot.Investigational testing: lot 1010407570 was expired prior to the customer contacting biomérieux about their issue, so no investigational testing with retain samples could be performed on this particular lot.Biomérieux requested the customer provide the strain for further testing, but the strain was not provided.Root cause: the cause for the customer's issue could not be determined.The lot was already expired prior to biomérieux being made aware of the customer's issue and the customer did not provide the strain for further testing.Conclusion: the investigation did not identify any product performance issue for chromid s.Aureus elite 20 pl (ref 419042, lot 1010407570).The cause for the customer's issue could not be determined.The lot was already expired prior to biomérieux being made aware of the customer's issue and the customer did not provide the strain for further testing.

• Brand Name: CHROMID S.AUREUS ELITE 20 PL - 419042
• Common Device Name: CHROMID S.AUREUS ELITE 20 PL - 419042
• Manufacturer (Section D): BIOMÉRIEUX SA; 5 rue des aqueducs; craponne 69290 ; FR 69290
• Manufacturer (Section G): BIOMÉRIEUX SA; 5 rue des aqueducs; craponne ; FR
• Manufacturer Contact: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 19264355
• Report Number: 9615755-2024-00002
• Device Sequence Number: 20456188
• Product Code: JSI
• UDI-Device Identifier: 03573026494445
• UDI-Public: 03573026494445
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/13/2024

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: 03/25/2024
• Device Catalogue Number: 419042
• Device Lot Number: 1010407570
• 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: 06/03/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown