MAUDE Adverse Event Report: BIOMÉRIEUX SA ETEST® VANCOMYCIN (VA); VANCOMYCIN VA 256 WW S30

Model Number 412488

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Intended use: etest® is a manual, quantitative technique for the determination of antimicrobial susceptibility of non-fastidious gram-negative and gram-positive aerobic bacteria and fastidious bacteria.The system comprises a predefined antibiotic gradient which is used to determine the minimum inhibitory concentration (mic, in g/ml) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation.Issue description: a publication in spain reported a high rate of false susceptible vancomycin results for vancomycin-resistant enterococcus species associated with vancomycin va 256 ww s30 (ref.(b)(4), lot unknown).At the time of assessment, there is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.Although vancomycin va 256 ww s30 - (b)(4) is not registered in the united states, a similar product vancomycin va 256 us s30-412486 is registered in the united states.

Manufacturer Narrative

This investigation was initiated following post market surveillance (pms), article (b)(4), related to the etest products vancomycin (va 256) and teicoplanin (tp 256).This article described a high percentage of discrepant minimum inhibitory concentration (mic) results especially for vancomycin (2% of mics discrepancies) and teicoplanin (9,2% of mics discrepancies) with vanb phenotype enterococcus faecium isolates.This study seems to highlight an underestimation of mic values with the two etest products mentioned above.Within the pms process, it was concluded that, based on this article, a further investigation should be done.To further investigate the article, the strains used during the study were necessary to perform in-house tests.Despite numerous attempts with the customer, we were unable to retrieve the requested strains.Thereby, no test can be performed at biomérieux.Trend analysis: on the 18th of october 2023, a complaint trend analysis was performed since 2021 on the etest products va 256 and tp 256.No trend related to performance issue and particularly related to mics underestimation was observed.Conclusion: as no strains were submitted, it was not possible to investigate further, nor to identify any root cause for the issue described in this article.No negative trend is detected for etest products va 256 and tp 256.As it was not possible to confirm any performance gap during this investigation for etest products va 256 and tp 256, neither corrective nor preventive action will be implemented.

Event Description

Intended use: etest® is a manual, quantitative technique for the determination of antimicrobial susceptibility of non-fastidious gram-negative and gram-positive aerobic bacteria and fastidious bacteria.The system comprises a predefined antibiotic gradient which is used to determine the minimum inhibitory concentration (mic, in ¿g/ml) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation.Issue description: a publication in spain reported a high rate of false susceptible vancomycin results for vancomycin-resistant enterococcus species associated with vancomycin va 256 ww s30 (ref.412488, lot unknown).At the time of assessment, there is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.Note: although vancomycin va 256 ww s30 - 412488 is not registered in the united states, a similar product vancomycin va 256 us s30-412486 is registered in the united states.

• Brand Name: ETEST® VANCOMYCIN (VA)
• Type of Device: VANCOMYCIN VA 256 WW S30
• Manufacturer (Section D): BIOMÉRIEUX SA; 3, route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMÉRIEUX SA; 3, route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 16241825
• MDR Text Key: 308202466
• Report Number: 9615754-2023-00003
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K980348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 412488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1