MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID® MRSA

Catalog Number 43451

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2017

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux a false resistant staphylococcus aureus for a nasal specimen in association with chromid® (b)(6) (lot 1005719760).The customer reported there was growth of staphylococcus aureus without gene mec or plp 2.The patient sample was acquired with a nasal swab (eswab) containing transport medium.The specimen showed growth in 24 hours as typical green colonies on mrsa plates incubated at 35°c.Test results for the sample: on (b)(6) 2017 - mic >=2 mg/l - negative.No diameters were provided by the customer and no pcr performed.The detection of plp2a was performed using immuno-chromatography.The customer reported that no incorrect result was reported to a physician and there was no impact to patient treatment.There was a delay greater than 24 hours for reporting results.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: for all samples, the customer reported that direct inoculation, nylon flocked swabs with transport medium (eswab) was used.Each specimen showed growth of typical green colonies on the chromid® mrsa plates at 24 hours of incubation at 35°c.The customer reported minimum inhibitory concentrations of <=2 mg/l and negative results for plp2a.The customer reported that detection of plp2a was performed using immuno-chromatography.The customer did not retain the strains in question, it was therefore not possible to include them in the investigation.At the time of the investigation lot number 1005719760 had already expired, it was therefore not possible to analyze the retained biomérieux samples.The investigation consisted of a review of complaints registered for the impacted lot number and a review of the lot number file.In conclusion, complaint trend analysis for the impacted lot number indicated that no other complaints were registered for this lot.A review of the impacted lot number file indicated that the product conformed with specifications.The patient strains in question were not available to test as part of the investigation, it was therefore not possible to determine the root cause of the issue observed by the customer.The customer reported that test results for the patient strains were negative for plp2a, the limitations section of the package insert states " certain strains of s.Aureus which do not have the mec a gene may develop typical colonies on this type of medium after 24 or 48 hours of incubation." corrective and preventive actions will not be implemented as the product is performing within specification.

• Brand Name: CHROMID® MRSA
• Type of Device: CHROMID® MRSA
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne, fr 69290 ; FR 69290
• Manufacturer (Section G): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne, fr 69290 ; FR 69290
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6828647
• MDR Text Key: 83947457
• Report Number: 3002769706-2017-00256
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K091024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2017
• Device Catalogue Number: 43451
• Device Lot Number: 1005719760
• Other Device ID Number: 03573026136642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1