BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETEST® ERTAPENEM ETP 32 WW B30

    MDR report key: 6354960 · Received February 23, 2017

    Report

    Report Number
    3002769706-2017-00036
    Event Type
    Malfunction
    Date Received
    February 23, 2017
    Report Date
    June 30, 2017
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    JWY
    PMA / PMN Number
    K020748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION: THIS INVESTIGATION WAS INITIATED DUE TO A DISCREPANCY BETWEEN ETEST® ETP 32 (ERTAPENEM) REFERENCE 531600 BLISTER, RESULT OF SUSCEPTIBLE(S) OBTAINED BY THE CUSTOMER AND THE EXPECTED RESULT BY THE NEQAS SURVEY RESISTANT(R/I ). THE STRAIN IS AN ENTEROBACTER CLOACAE COMPLEX NEQAS # (B)(4). DURING IDENTIFICATION TESTING, TESTING CONFIRMED RESULT OF ENTEROBACTER CLOACAE ON VITEK® 2 GN CARD. CLSI 2017 BREAKPOINTS ENTEROBACTERIACEAE -ERTAPENEM [ S LESS THAN OR EQUAL TO 0.5 - 1 - GREATER THAN OR EQUAL TO 2 R ] . EUCAST 2017 BREAKPOINTS ENTEROBACTERIACEAE -ERTAPENEM [ S LESS THAN OR EQUAL TO 0.5 - > 1 R ]. · REFERENCE METHOD USED FOR ETEST® DEVELOPMENT: AGAR DILUTION (AD) : ETP MIC = 0.5 MG/L : S. · REFERENCE METHOD RECOMMENDED BY NEQAS : BROTH MICRODILUTION (BMD) : ETP MIC = 1 MG/L : I. · MECHANISM OF RESISTANCE DETECTION: PCR IMP, OXA48 LIKE, KPC, NDM AND VIM NEGATIVE (ESSAY MSAST-465). ·A REPRODUCIBILITY STUDY WAS PERFORMED ON ETEST®. ALL QC STRAINS WERE CONFORM (PSEUDOMONAS AERUGINOSA ATCC 27853, ESCHERICHIA COLI ATCC 25922, STAPHYLOCOCCUS AUREUS ATCC 29213, ENTEROCOCCUS FAECALIS ATCC 29212, BACTEROIDES FRAGILIS ATCC 25285, STREPTOCOCCUS PNEUMONIAE ATCC 49619, HAEMOPHILUS INFLUENZAE ATCC 49766) AND THE NEQAS STRAIN GAVE MIC EQUAL TO 0.5 MG/L S. BIOMÉRIEUX REPRODUCED THE CUSTOMER RESULTS OF SUSCEPTIBLE (S). ETEST® ETP (MIC 0.5 ¿G/ML S) IS AN ESSENTIAL AGREEMENT WITH THE REFERENCE MIC 0.5 MG/L OBTAINED WITH AGAR DILUTION (METHOD USED FOR THE DEVELOPMENT OF ETEST ETP STRIP ) , WITHOUT CATEGORY ERROR. ETEST® ETP STRIP PERFORMED AS INTENDED, AND NO FURTHER ACTION IS REQUIRED. THE BROTH MICRODILUTION WHICH IS THE METHOD USED BY NEQAS, WAS ALSO PERFORMED. IT GAVE AN ETP MIC EQUAL TO 1 MG/L I. THIS RESULT IS IN THE MIDDLE OF THE CLSI BREAKPOINTS, SO WITHIN 1 DOUBLING DILUTION THE CATEGORY CAN BE S OR R.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX A FALSE SUSCEPTIBLE ERTAPENEM RESULT FOR AN EXTERNAL QUALITY CONTROL SAMPLE (NEQUAS 3419) IN ASSOCIATION WITH ETEST® ERTAPENEM ETP 32 WW B30. THE CUSTOMER REPORTED THAT THE RESULT OF THE ETEST® WAS SENSITIVE (MIC 0.5) SEVERAL TIMES. THE EXPECTED RESULT WAS INTERMEDIATE OR RESISTANT AND THE CUSTOMER STATED THAT DISK DIFFUSION GAVE THE CORRECT RESULT. A BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136610 ETEST® ERTAPENEM ETP 32 WW B30 ETEST® ERTAPENEM ETP 32 WW B30 JWY BIOMERIEUX, SA 1003530750

    Patients

    Seq Age Sex Outcome Treatment
    1