MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID® MRSA SMART

Catalog Number 413051

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux a false negative result for a (b)(6) strain on a chromid® mrsa smart (lot 1006023560) plate.The customer stated a specific strain of staphylococcus aureus did not grow on the chromid® mrsa smart plate.The strain was cultured on chromid® mrsa smart, chromid® s.Aureus elite, and blood agar.The s.Aureus only grew on the blood agar.The customer then performed disc testing and found the strain to be cefoxitin resistant.It was then cultured from the original sample tube to a new mrsa smart plate and a bd chromagar mrsa plate, and there was no growth on the mrsa smart plate and full growth on the chromagar mrsa plate.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from sweden reported to biomérieux a false negative result for a mrsa strain on a chromid® mrsa smart (lot 1006023560) plate.The customer stated a specific strain of staphylococcus aureus did not grow on the chromid mrsa smart plate.The customer provided photos and the strain in question for the investigation.An investigation was performed.The photos showed full growth of the strain on a mrsa plate manufactured by bd.The chromid mrsa smart agar plate had only residues from bacteria that survived in the tube.A review of the manufacturing quality records for chromid mrsa smart (lot 1006023560) confirmed the product was controlled and conformed with specifications.There were no non-conformities on this lot number.Testing was performed on the retained samples for the impacted lot number in order to verify if the microbiological performance of the impacted lot number was in accordance with the quality control protocol.The impacted lot number (1006023560) was tested in parallel with a reference lot number (1006032860).All the results conformed with specifications.The retained sample plates comply with expected specifications, notably in terms of fertility.The customer's strain was identified as a mrsa strain.As the impacted lot number had expired at the time the strain was received, the strain was tested on three different lot numbers of chromid mrsa smart at different stages of their shelf life; start, middle and end.The customer's issue was confirmed on lot numbers; 1006062380 expiry 09-jan-2018, 1006130250 expiry 08-feb-2018, 1006176420 expiry 28-feb-2018.The identification of an mrsa strain was confirmed by pcr; meca positive and kirby bauer cefoxitin (fox kb ) resistant.It was determined that the lack of sensitivity of chromid mrsa smart is due to the atypical susceptibility of the strain to one of the component's present in the medium.The strain was therefore determined to be an atypical strain.The investigation confirmed the issue that the customer observed on the mrsa strain.The strain provided was determined to be an atypical strain as it is susceptible to one of the component's present in the medium.Microbiological activity testing on the impacted lot number indicated that the lot was performing within specifications.

• Brand Name: CHROMID® MRSA SMART
• Type of Device: CHROMID® MRSA SMART
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne, fr 69290 ; FR 69290
• MDR Report Key: 7164052
• MDR Text Key: 97478801
• Report Number: 3002769706-2018-00002
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• PMA/PMN Number: K091024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2017
• Device Catalogue Number: 413051
• Device Lot Number: 1006023560
• Other Device ID Number: 03573026390815
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1