BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-N233 TEST KIT

    MDR report key: 8048520 · Received November 7, 2018

    Report

    Report Number
    1950204-2018-00475
    Event Type
    Malfunction
    Date Received
    November 7, 2018
    Report Date
    March 29, 2018
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    K040845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WAS INITIATED DUE TO INACCURATE ESBL PHENOTYPES PROPOSED FOR ESCHERICHIA COLI ON VITEK® 2 V8.01 AST-N233 CARDS. THE CUSTOMER PERFORMED MANUAL ESBL CONFIRMATION WITH MUELLER-HINTON CLOXACILLIN AGAR, AND IT WAS NEGATIVE. THE SUBMITTED CUSTOMER STRAIN WAS SUBCULTURED ON CBA (COS BMX) AND CPSE MEDIA. IDENTIFICATION WAS CONFIRMED TO ESCHERICHIA COLI WITH THE VITEK 2 GN CARD. THE PRESENCE OF AN ESBL WAS CHECKED BY THE PHENOTYPIC REFERENCE METHODS: ESBL SCREENING TEST USING COMBINED DISCS (CEFTAZIDIME +/- ACID CLAVULANIC, CEFOTAXIME +/- ACID CLAVULANIC, CEFEPIME +/- ACID CLAVULANIC) ON MUELLER-HINTON +/- CLOXACILLIN: - DIFFERENCE OF INHIBITION DIAMETERS BETWEEN ATB DISC WITH OR WITHOUT CLAVULANIC ACID < 5 MM, NEGATIVE RESULT. THIS STRAIN IS NOT AN ESBL-PRODUCING BACTERIA. - INCREASE OF DIAMETERS INHIBITION BETWEEN BOTH MEDIA WITH OR WITHOUT CLOXACILLIN : INDICATING PRESENCE OF HIGH LEVEL CEPHALOSPORINASE (AMPC). THE STRAIN WAS THEN SEQUENCED TO DETERMINE THE EXPECTED PHENOTYPE. GENES ESC, TEM-1 AND DHA WERE IDENTIFIED CONFIRMING THAT THIS STRAIN WAS NOT AN ESBL BUT MOST LIKELY A HIGH LEVEL CEPHALOSPORINASE AMPC. VITEK 2 TESTING WAS PERFORMED INCLUDING AST-N233 + XN05 FROM THE CUSTOMER LOT (CL: 6330664203 - 1480689203) AND A 1 RANDOM LOT (RL: 6330817403 - 1480790203) WITH VITEK 2 SOFTWARE VERSION V8.01. AES PHENOTYPES "EXTENDED SPECTRUM BETA-LACTAMASE " WERE PROPOSED WHATEVER THE CARDS, THE LOTS AND MEDIA TESTED. ON AST-N233+XN05 CARD, AES PROPOSED THE PHENOTYPE ESBL WITH NEGATIVE ESBL TEST BUT BIOLOGICALLY CORRECTED TO POSITIVE BY THE AES. THE MICS OF PIPERACILLIN-TAZOBACTAM, CEFTRIAXONE, CEFTAZIDIME, CEFOTAXIME DON'T MATCH WITH THE EXPECTED PHENOTYPE "HIGH LEVEL CEPHALOSPORINASE" AMPC. VITEK 2 GAVE TZP </= 4 MG/L S , CRO </= 1 MG/L S, CAZ = 4 MG/L I, AND CTX </= 1 MG/L S. (SAME MICS ON ALL THE LOTS, CARDS, MEDIA). SO THE REFERENCE METHODS WERE PERFORMED TO CHECK THE MICS: - MICRODILUTION (BMD) WHICH WAS THE METHOD USED FOR TZP DEVELOPMENT (FORMULATION TZP03) ON THE AST-N233 CARD. - AGAR DILUTION (AD) WHICH WAS THE METHOD USED FOR CAZ, CRO AND CTX DEVELOPMENT (FORMULATION CAZ01N, CRO01N, CTX01N) ON THE AST-N233 CARD. REF TZP MIC = 2 MG/L S REF CRO MIC = 0.5 MG/L S REF CAZ MIC = 4 MG/L I REF CTX MIC = 2 MG/L I THE VITEK 2 VALUES FOR TZP, CAZ, CRO, AND CTX MICS ARE IN AGREEMENT WITH THE REFERENCE MIC WITHOUT ANY CATEGORY ERROR EXCEPT FOR CTX WHICH REMAINS A MINOR ERROR OF CATEGORY. CONCLUSION: THE AES PROPOSED ESBL PHENOTYPE IS REPRODUCED IN-HOUSE WHATEVER THE CARDS, THE LOTS AND MEDIA TESTED. UNUSUAL PROFILE FOR A STRAIN WITH A HIGH LEVEL CASE (AMPC).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK® 2 AST-N233 TEST KIT. THE CUSTOMER REPORTED THAT AN INACCURATE ESBL (EXTENDED-SPECTRUM BETA-LACTAMASE) PHENOTYPE WAS PROPOSED FOR AN ESCHERICHIA COLI PATIENT STRAIN. INITIAL TESTING WAS PERFORMED WITH THE AST-N372 CARD. THE CUSTOMER REPEATED TESTING WITH THE AST-N233 (+XN05) CARD AND THE ESBL PHENOTYPE WAS ALSO PROPOSED. THE CUSTOMER PERFORMED MANUAL ESBL CONFIRMATION WITH MUELLER HINTON CLOXA AGAR AND IT WAS NEGATIVE INDICATING NO ESBL. THE CUSTOMER STATED THE RESULT WAS NOT REPORTED TO THE PHYSICIAN AND THERE WAS NO IMPACT TO THE PATIENT. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888116 VITEK® 2 AST-N233 TEST KIT VITEK® 2 AST-N233 TEST KIT LON BIOMERIEUX, INC. 6330664203

    Patients

    Seq Age Sex Outcome Treatment
    1