MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID® VRE AGAR

Catalog Number 43004

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported a false resistant result for a vancomycin-susceptible enterococcus faecalis strain from a rectal swab, in association with the chromid® vre agar.The customer stated the vancomycin-susceptible strain with typical color of vre, exhibited growth on the chromid® vre agar after 24 hours; organism growth should have been inhibited.The strain was tested with the vitek® 2 ast-p586 card and was vancomycin susceptible (mic=1).The pcr result was van-a/b negative.The customer was not able to retest, as the isolate could not be re-cultivated on a vre plate.The customer reported the initial incorrect result was reported to a physician but was corrected.The customer stated there was no impact to patient treatment.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer reported a false resistant result for a vancomycin-susceptible enterococcus faecalis strain in association with the chromid® vre agar.An investigation was performed.A review of the manufacturing records for lot number: 1006145660 confirmed the lot was within specifications and no nonconformance or deviation was recorded.Analysis was performed on the retained sample plates for lot: 1006145660 and on a reference lot number: 1006126820.Testing was performed in order to verify if the microbiological performance of the impacted lot number was in accordance with the quality control protocol for ref: (b)(4).All results conformed with specifications.Good inhibition of the vancomycin susceptible enterococcus faecalis strain was observed.The customer returned two impacted strains for the investigation.The strains were identified with vitek® ms, then tested with etest® in order to determine their mic (minimum inhibitory concentration) to vancomycin.The strains were tested on sample plates of lot: 1006145660 on a reference lot: 1006126820.Customer strain number: (b)(4) was identified as enterococcus faecium.Characteristic purple colonies of vre were observed after 24 hours of incubation.The mic of the strain to vancomycin was determined to be equal to the concentration of vancomycin in the media.Therefore, the strain is considered as being borderline and growth of colonies is possible.Customer strain number: (b)(4) was identified as enterococcus faecalis.No growth was observed after 48 hours of incubation.The mic of the strain to vancomycin was determined to be less than the concentration of vancomycin in the media.Therefore, the strain is susceptible to vancomycin and no growth was observed on the impacted lot number.The investigation did not reproduce the issue observed by the customer.As a conclusion, the results obtained on the customer strains are expected in terms of their mics to vancomycin.The review of the manufacturing records did not make any connection with the issue observed by the customer.Testing demonstrated that the microbiological performance of chromid vre agar lot: 1006145660, reference: (b)(4) is within specifications.

• Brand Name: CHROMID® VRE AGAR
• Type of Device: CHROMID® VRE AGAR
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne, fr 69290 ; FR 69290
• MDR Report Key: 7260428
• MDR Text Key: 100124408
• Report Number: 3002769706-2018-00014
• 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: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2018
• Device Catalogue Number: 43004
• Device Lot Number: 1006145660
• Other Device ID Number: 03573026257972
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1