MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID® VRE

Catalog Number 43004

Device Problem Contamination (1120)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomerieux of a contaminated product issue associated with chromid vre id agar (reference (b)(4)).The customer reported molds appeared after product incubation.Patient results were not affected, erroneous results were not reported to a physician and the patient was not harmed or treated inappropriately.However, the customer indicated there was a delay in reporting results.

Manufacturer Narrative

A customer in germany had notified biomérieux of a contaminated product issue associated with chromid® vre id agar (reference (b)(4).The customer reported molds appeared after product incubation.An internal biomérieux investigation was performed.The customer submitted one strain for further evaluation.This investigation consisted of a review of the batches records, an analysis of the biomérieux retained references samples and an analysis of the strain returned by the customer.The review of the batches records indicated that no discrepancies were detected during the manufacturing.Results of quality control laboratory were in accordance with specifications as indicated in the quality certificate.Bacteriological analysis was performed on retained samples of the two incriminated batches (lot 1004708310 and lot 100469042) and the customer strain.Vitek® identification confirmed stenotrophomonas maltophilia for the strain.This result was consistent with the customer identification.Inoculation of the retained samples of incriminated batch of chromid vre (1004708310, exp.Date 24-may-2016 and 1004690420, exp.Date 18-may-2016) and of two references batches of chromid vre, one batch at the middle shelf life (1004785280, exp.Date 24-jun-2016) and another batch at the end shelf life (1004677490, exp.Date 11-may-2016) was performed following the quality control (qc) method for both quality control strains and the customer strain.There was good growth of the qc strains enterococcus faecalis vre and enterococcus faecium vre after 24 hours of incubation on both batches of chromid vre.In 48 hours, there was inhibition of enterococcus faecalis no vre, of enteroccus gallinarum (natural resistance), other gram positive and gram negative bacteria, and yeasts.These results were in accordance with the expected specifications.For the customer strain, there was no growth of typical colonies after 24 hours of incubation.In 48 hours, there was very low growth of one to two green colonies for one of the incriminated batches, 1004708310.This result was consistent with the limitations in the package insert.The defect observed by the customer was not reproduced in 24 hours.The review of batches records does not indicate a connection with the issue observed by the customer.This investigation concluded that performance of chromid vre id agar (reference (b)(4) batch number 1004708310 and 1004690420 is within specifications and in accordance with the data indicated in the package insert.It is written that some microorganisms other than enterococci may develop on the medium and produce typical colonies, but which generally differ morphologically.The picture transmitted by the customer shows in 48 hours, the aspect of the colonies were not characteristic: colonies were very big, yellow at the outside, and green on the center.The issue observed by the customer could be related with a defect of preservation of the product.

• Brand Name: CHROMID® VRE
• Type of Device: CHROMID® VRE
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne, fr 69290 ; FR 69290
• MDR Report Key: 5623947
• MDR Text Key: 44150900
• Report Number: 3002769706-2016-00079
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• PMA/PMN Number: K091025
• 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: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2016
• Device Catalogue Number: 43004
• Device Lot Number: 1004708310
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1