MAUDE Adverse Event Report: BIOMERIEUX, SA MEROPENEM MP 32 WW S30

Catalog Number 412402

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.Description: an internal complaint was initiated following a review of a scientific publication from south africa entitled, "comparison of carbapenem minimum inhibitory concentrations of oxa-48-like klebsiella pneumoniae by sensititre, vitek 2, microscan and etest" by nana t, et al.This publication noted potential false susceptible ertapenem, meropenem, and imipenem results for klebsiella pneumoniae isolates when analyzed with etest® products compared to results obtained with vitek® 2, sensititre, and microscan products.This assessment is for the implicated product of meropenem mp 32 ww s30 (ref 412402).The article presents a study in which the aim was to compare carbapenem mics for 82 oxa-48-like k.Pneumoniae isolates between several methods including etest strips.The data presented in the publication shows that discrepant results were sometimes obtained when comparing the various methods.The proportion of isolates testing susceptible to ertapenem by etest (19/82, 23.1%) differed from sensititre/vitek (0/82) and microscan (2/82, 2.4%) (p < 0.001).For meropenem the 47 proportion of isolates susceptible by etest (31/82, 37.8%) 48 differed from sensititre/vitek (16/82, 19.5%) (p=0.015) and for imipenem they observed inconsistency with the different methods.However, the authors clearly documented a major limitation of this study where the isolates were not analyzed using the reference method, broth microdilution (bmd), to determine the expected mic and interpretation (susceptible/intermediate/resistant).This was a retrospective study performed on isolates that were selected from a list of carbapenem-resistant enterobacterales (cre) that were collected between 2017-2021.There is no indication or report in the publication that any results obtained during the study were used for any treatment decisions.There is no indication or report of any adverse events related to any patient's state of health.Note: etest® meropenem mp 32 ww s30 (ref 412402) is not registered for use in the united states.However a similar product, etest® meropenem mp 32 us s30 (ref 412401), is registered for use in the united states (k010363).An investigation has been initiated.

Manufacturer Narrative

An investigation was initiated in response to a scientific publication from south africa entitled, "comparison of carbapenem minimum inhibitory concentrations of oxa-48-like klebsiella pneumoniae by sensititre, vitek 2, microscan and etest" by nana t, et al.This publication noted potential false susceptible ertapenem, meropenem, and imipenem results for klebsiella pneumoniae isolates when analyzed with etest® products compared to results obtained with vitek® 2, sensititre, and microscan products.This assessment is for the implicated product of meropenem mp 32 ww s30 (ref (b)(4)).Investigation: complaint trend analysis: global customer service (gcs) performed a complaint trend analysis and did not identify the reported issues as trends for the etest products.Investigational testing: to further investigate the article, the strains used during the study were necessary to perform in-house tests.A material transfer agreement (mta) must be signed between the author and biomérieux, but unfortunately no consensus has been reached between the two parties on the dissemination of future data generated by biomérieux.Therefore, no further testing can be performed at biomérieux.Root cause: the cause for the issue could not be determined.As no strains were submitted, and since a bias related to local epidemiology cannot be excluded, it was not possible to confirm the reported issues or to identify any root cause for the reported issues.Conclusion: the cause for the reported false susceptible etest results could not be determined.No investigational testing could be performed to confirm the results obtained by the publication authors.No trend is observed in the complaints search related to the issue described in the article for etest products etp 32, mp 32 and ip 32.There is no indication of a systemic product performance issue.

• Brand Name: MEROPENEM MP 32 WW S30
• Type of Device: MEROPENEM MP 32 WW S30
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 15252991
• MDR Text Key: 305523824
• Report Number: 9615754-2022-00099
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K010363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 412402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2023
• 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