MAUDE Adverse Event Report: BIOMERIEUX SA ETEST IMIPENEM; ETEST® IMIPENEM

Catalog Number 412374

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A complaint was opened by biomérieux following postmarket surveillance internal review of an article from italy, "variable performance of different commercial systems for testing carbapenem susceptibility of kpc carbapenemase-producing escherichia coli," authored by alberto antonelli, marco coppi, giulio camarlinghi, eva maria parisio, maria nardone, eleonora riccobono, tommaso giani, romano mattei and gian maria rossolini.The article noted a trend for etest® imipenem (ref.412374, lot # not specified) to underestimate resistance (false susceptible) when compared to the bmd method for kpc carbapenemase-producing escherichia coli patient strains.As these isolates were tested as part of this scientific study, there was no patient directly associated with the testing.Therefore, there was no adverse impact to any patient's state of health as a result of the testing.Additionally, the article contact confirmed there was no impact on patient therapy or outcome due to the results.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following postmarket surveillance internal review of an article from italy, "variable performance of different commercial systems for testing carbapenem susceptibility of kpc carbapenemase-producing escherichia coli," authored by alberto antonelli, marco coppi, giulio camarlinghi, eva maria parisio, maria nardone, eleonora riccobono, tommaso giani, romano mattei and gian maria rossolini.The article noted a trend for etest® imipenem (ref.412374, lot # not specified) to underestimate resistance (false susceptible) when compared to the bmd method for kpc carbapenemase-producing escherichia coli patient strains.A biomérieux internal investigation has been completed with the following results: a performance analysis was performed on a panel of 22 internal e.Coli kpc producer strains.The strains were tested with etest ertapenem (etp32) and meropenem (mp32).In addition, a panel of 23 e.Coli kpc producer strains were tested with etest imipenem (ip 32).In parallel, the minimum inhibitory concentration (mic) of the three (3) carbapenems molecules for the 22/23 strains were evaluated with the reference method agar dilution (ad) and with the reference method broth micro dilution (bmd).Ad is the reference method that has been used for the development of the three (3) etest strips and the bmd is the reference method used in the scientific article.The reading and the interpretation of the mic were made following eucast standards.A lot of each etest strip type was chosen randomly for this study.The quality control (qc) tests were performed with atcc® strains mentioned in the package insert of each product.All the results obtained were in agreement with the quality control specifications for all the qc strains tested for the 3 products, etest ip 32, mp 32 and etp 32.The identification of the 23 strains selected for the study was confirmed on vitek® 2 v9.02 gn card.The following are the results obtained with the panel of e.Coli kpc strains: -for ertapenem, etest mics were within essential agreement compared to the ad mics for 19/22 strains without any category error for 18 strains.Globally, one major error and two very major errors were detected.-for imipenem, etest mics were within essential agreement compared to the ad mics for 16/23 strains without any category error.Globally, two very major errors, one major error and two minor errors were detected.-for meropenem, etest mics were within essential agreement compared to the ad mics for 18/22 strains without any category error for 15 strains.Globally, four minor errors were detected.Bmd mics are globally found higher than ad mics (up to 4 doubling dilutions).This may explain some of the differences observed especially the strains which mics are underestimated with etest compared to bmd and then the vme that are observed.Indeed etest strips are calibrated with ad reference method and carbapenem mics are sometimes found much higher by a liquid method (bmd) than by a solid method (ad), in particular on some strains producing carbapenemase heterogeneously.It should also be noted that the reading for etest etp32, ip32 and mp32 strips is difficult on such strains.Microcolonies in the inhibition zone, tunnel are observed and may impact the reproducibility of the results.Such behavior are common for enterobacterales producing carbapenemase.Those results remained within the expected level of the etest strips performance knowing that this study is focusing on a specific part of the strips claims (e.Coli kpc) and that the strains selection is not representative of an usual epidemiology.A larger study has been performed prior this investigation to compare the etest ertapenem, imipenem and meropenem mics to bmd.It was performed on a larger set of strains and not focused on e.Coli kpc to make it representative of an usual epidemiology.Results were in agreement with the expected level of performance.In conclusion, the performance analysis with a panel of 23 internal strains of e.Coli kpc producer with product etest ip 32, etest mp 32 and etest etp 32 showed that there is no drift in the performance of the three (3) products.This investigation did not highlight any performance issues for the three products.

• Brand Name: ETEST IMIPENEM
• Type of Device: ETEST® IMIPENEM
• Manufacturer (Section D): BIOMERIEUX SA; 3 route de port michaud; la balme les grottes isere 383, ; FR
• MDR Report Key: 9771097
• MDR Text Key: 206148809
• Report Number: 9615754-2020-00036
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• PMA/PMN Number: K960989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 412374
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1