MAUDE Adverse Event Report: BIOMERIEUX SA CHROMID MRSA 20 PLT

Catalog Number 43451

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Intended use: chromid" (b)(6) agar is a chromogenic medium for the screening of (b)(6) in chronic carriers or patients who are at risk for (b)(6).This medium does not replace conventional antimicrobial susceptibility tests.(b)(6) are multi-resistant bacteria which may cause nosocomial infections.The detection of (b)(6) carriers is particularly important for the epidemiological prevention and monitoring of these infection.In this context, the use of chromid" (b)(6) agar contributes towards the active surveillance of (b)(6).Description of the issue: a client in (b)(6) notified biom¿rieux of obtaining a non-colored quality control staphylococcus (b)(6) on chromid (b)(6) 20 plt - (reference 43451- lot #1008569330, expiry date 07/05/2021).The colonies grew white instead of the expected green.This constitutes a false negative result.As it concerns a quality control test, no patient impact has been reported.A biom¿rieux internal investigation will be initiated.

Manufacturer Narrative

Lot number record analysis.The lot was manufactured the (b)(6) 2021.(b)(6) kits ((b)(6) plates) were released with an expiry date of 07-may-2021.Quality control tests are performed in order to release the product.The following controls were carried out: - control of the microbiological state and appearance of the product: 138 plates were incubated at 20-25°c and 140 plates were incubated at 33-37°c during four (4) days.The results conformed with specifications: absence of contamination and appearance defects.- microbiological activity controls were performed at 33-37°c with the following strains: staphylococcus aureus atcc 43300 mrsa; good growth with a green characteristic color after 18-24h incubation was obtained.Staphylococcus aureus atcc 29213, escherichia coli atcc 8739, candida albicans atcc 10231; total inhibition after 48h incubation was obtained.Enterococcus faecalis atcc 29212; total inhibition after 18-24h of incubation was obtained.Two (2) additional internal strains of staphylococcus aureus (05-04-605 & 05-06-614): total inhibition after 18-24h incubation was obtained.All the quality controls with all the atcc strains conformed with specifications.- the ph of the product was controlled and conformed with specifications.The quality control for lot number 1008569330, reference 43451, conformed with specifications.Non-conformities were not registered on this lot number.Complaint analysis.Complaint analysis has been performed and did not indicate any systematic quality issue.Conclusion: ****************** the lot number record analysis indicated that the impacted lot 1008569330 complies with our specifications and non-conformances were not recorded on this lot.As no product issue was detected, neither corrective nor preventive actions will be implemented.Since the lot was expired at the time of the investigation, it was not possible to perform further investigation.It has been recommended to protect the product chromid¿ mrsa agar (mrsa) plate, reference 43451, from light and limit the light exposure to inoculation time only.

• Brand Name: CHROMID MRSA 20 PLT
• Type of Device: CHROMID MRSA 20 PLT
• Manufacturer (Section D): BIOMERIEUX SA; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 11890265
• MDR Text Key: 267836633
• Report Number: 9615755-2021-00007
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• PMA/PMN Number: K162076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2021
• Device Catalogue Number: 43451
• Device Lot Number: 1008569330
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1