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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA ETEST ERTAPENEM ETEST® ERTAPENEM

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BIOMERIEUX SA ETEST ERTAPENEM ETEST® ERTAPENEM Back to Search Results
Catalog Number 531600
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 (b)(6), "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® ertapenem (ref. 531600, 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.
 
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Brand NameETEST ERTAPENEM
Type of DeviceETEST® ERTAPENEM
Manufacturer (Section D)
BIOMERIEUX SA
3 route de port michaud
la balme, les grottes 38390
FR 38390
Manufacturer (Section G)
BIOMERIEUX, SA
3 route de port michaud
la balme, les grottes isere 38390
FR 38390
Manufacturer Contact
danielle cooper
595 anglum road
hazelwood, MO 63042
MDR Report Key9771234
MDR Text Key206148458
Report Number9615754-2020-00038
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
PMA/PMN Number
K020748
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received02/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number531600
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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