MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID MRSA 20 PLT US; CHROMID® MRSA 20 PLT US

Catalog Number 43841

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Event Description

A customer in the united states reported the occurrence of a (b)(6) result for a (b)(6) patient strain when using chromid¿ (b)(6) agar (ref.43841, lot 1008438600).The source of the strain is unknown (i.E.Blood, skin, etc.).The customer reported that when they plated the sample on the chromid¿ (b)(6) media, growth was observed on the plate but it did not turn green after 24 hours as a (b)(6) strain should.The customer also tested the strain on vitek¿ 2 and obtained a (b)(6) identification and a oxacillin resistant result.The customer repeated the test and still obtained (b)(6) result on chromid¿ (b)(6).The instructions for use (ifu) state in the limitations of the product: "rare (b)(6) strains may grow on chromid¿ (b)(6) without producing green color at 24 hours." there is no information from the customer that this event led to a delay of result or impacted the patient state of health.A biom¿rieux internal investigation will be initiated.

Manufacturer Narrative

On 21 jan 2021 a customer from the united states notified biomérieux that they observed a false negative mrsa result in association with chromid® mrsa agar (ref.(b)(4)) lot 1008438600; expiration 26 feb 2021).They identified mrsa using the vitek® 2 and it was oxacillin resistant.But when inoculated on the mrsa agar plate, the colonies did not turn green.Lot investigation the investigator reviewed the production records for this lot.The quality controls for lot number 1008438600 (ref.(b)(4)) complied with specifications.No non-conformities or deviations were recorded for this lot number.A review of the biomérieux complaints database did not find any other complaints reported against the customer¿s lot number (1008438600).Lot testing retained samples from the lot in question were tested in parallel with a reference lot number (1008443520; exp.02 mar 2021) using several quality control organism strains.Good growth and development of the green color (for mrsa ¿ staphylococcus aureus atcc® 43300) were observed at 24 hours of incubation.All of the results were equivalent and also within specifications.The customer was unable to submit a sample of their strain, thus the biomérieux complaints laboratory could not investigate the patient strain directly.Conclusion no corrective or preventative action is required at this time.Analysis of production records as well as tests using retained samples from the lot showed that it complied with specifications and no anomalies were observed.Additionally, no recurrent, frequent or systematic issues have been recorded for this lot.(1008438600).

• Brand Name: CHROMID MRSA 20 PLT US
• Type of Device: CHROMID® MRSA 20 PLT US
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 11337080
• MDR Text Key: 243793449
• Report Number: 9615755-2021-00003
• Device Sequence Number: 1
• Product Code: JSO
• UDI-Device Identifier: 03573026313111
• UDI-Public: 03573026313111
• Combination Product (y/n): N
• PMA/PMN Number: K162076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2021
• Device Catalogue Number: 43841
• Device Lot Number: 1008438600
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1