MAUDE Adverse Event Report: BIOMERIEUX SA ETEST® VANCOMYCIN VA 256 WW S30

Catalog Number 525518

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Event Description

On (b)(6) 2018, a eucast member reported to biomérieux a potential publication related to the underestimation of mic value for enterococci with a low level of resistance, in association with etest® vancomycin va 256 ww s30 (ref.(b)(4)).The eucast development laboratory confirmed the findings from a (b)(6) reference laboratory for resistant enterococci strains (mic value >4 mg/l) with a van b genotype regarding an underestimation of the mics value with etest® vancomycin va 256 (ref.(b)(4)) that led for some of the isolates to a susceptible result on etest® instead of resistant.The study compared etest® vancomycin to the broth micro dilution reference method and the results were: essential agreement: 63%, category agreement: 38%, false susceptible: 63%.No patient outcomes were reported due to the referenced issue.There is no indication or report that the discrepant results led to any adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated and impacted strains were requested.

Manufacturer Narrative

An internal investigation was performed when a eucast member reported to biomérieux a potential underestimation of minimum inhibitory concentration (mic) value for enterococci vanb-positive strains with a low level of vancomycin resistance associated with etest® vancomycin va 256 ww s30 (ref.412488).Eucast had confirmed the findings and published a warning on their website regarding the use of etest¿ (biomérieux), mts (liofilchem) and m.I.C.E.(oxoid/thermofisher) strips for vancomycin mic determination with enterococcus faecalis (e.Faecalis) and enterococcus faecium (e.Faecium) isolates with low-level vancomycin resistance.Complaints trend analysis: no other complaint was reported linked with this issue.One investigation was performed on etest va 256 about a discrepancy between vitek® 2 (resistant result obtained) and etest (susceptible result obtained) with an e.Faecium vanb.The broth micro dilution (bmd) method gave a mic value of 8 ¿g/ml and etest gave a mic value of 4 ¿g/ml, so a difference of one dilution only.The complaint trending analysis shows no systemic issues for the product etest vancomycin va 256.Strains studies: internal investigation was performed with the 24 strains (23 e.Faecium strains and 1 e.Faecalis strain) coming from the norwegian reference laboratory.The customer issue was partially reproduced internally but the discrepancies observed are lower when compared with customer's results.This can be explained by the fact that the results correlation between bmd method and etest method is better when a reading is made after an incubation of 24 hours (as mentioned in the instructions for use) instead of 18 hours; and with etest® va 256 method, the micro-colonies must be taken into account during the reading of the mic value.Furthermore, we tested these strains with the ad (agar dilution) method.We observed results discrepancy between the ad reference method results and the bmd reference method results.The ad mic values are lower when compared to bmd method.The results obtained with etest® va strips are in agreement with those obtained with ad method.We can say that there is no shift of performances for etest® va 256 when compared to the ad reference method used for the development of this etest strip.Additional studies on etest® va were performed with strains from our internal collection.The readings were made after 18h and 24h of incubation.As a conclusion per eucast and clsi interpretative criteria, etest® va 256 performances were within specifications.Conclusion performance of etest® va 256 was established using ad as reference method and no shift in product performance was observed during this investigation when compared to the ad method.No issue were detected when testing internal strains.Etest va 256 product performance remained within the specifications when e.Faecium van a/vanb + or e.Faecalis van a/van b+ were tested.24 hour reading is indicated to improve the detection of the low level resistance mechanism as recommended in the etest® user manual.

• Brand Name: ETEST® VANCOMYCIN VA 256 WW S30
• Type of Device: ETEST® VANCOMYCIN VA 256 WW S30
• Manufacturer (Section D): BIOMERIEUX SA; 3 route de port michaud; la balme les grottes isere 383, ; FR
• MDR Report Key: 7735896
• MDR Text Key: 115927385
• Report Number: 3002769706-2018-00123
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• PMA/PMN Number: K980348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2018
• Device Catalogue Number: 525518
• Device Lot Number: 1006011340
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1