BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-N350

    MDR report key: 8171770 · Received December 17, 2018

    Report

    Report Number
    1950204-2018-00702
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Report Date
    March 28, 2019
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    N50510: S103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PURPOSE OF THIS SUPPLEMENT REPORT IS TO MODIFY THE 510(K) NUMBER FROM "K040845" TO "N50510: S103". IT WAS DETERMINED THE EVENT WAS RELATED TO THE VITEK 2 SYSTEMS SOFTWARE ADVANCED EXPERT SYSTEM (AES) ESBL PHENOTYPE PROPOSAL, RATHER THAN THE ESBL TEST.

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION OF AN INACCURATE ESBL PHENOTYPE WHEN TESTING WITH THE AST-N350 CARD, (LOT 7900756403) AGAINST AN ESCHERICHIA COLI STRAIN. CUSTOMER ALTERNATIVE TESTING WAS MAST ESBL DISC TESTING WHICH GAVE A NEGATIVE ESBL RESULT. BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED USING THE PATIENT STRAIN SUBMITTED BY THE CUSTOMER. ORGANISM IDENTIFICATION WAS CONFIRMED TO E. COLI VIA VITEK® 2 GN ID CARD (LOT 2410545203). AST ALTERNATE METHODS TESTING INCLUDED: - PCR: CTX-M, SHV, NEGATIVE, AND TEM POSITIVE - WHOLE GENOME SEQUENCING: PRESENCE OF GENES ESC AND TEM-1 (MLST 12) INDICATES NO ESBL. - ESBL SCREENING TESTS WITH DISCS COMBINED ON MH +/- CLOXACILLIN, CONFIRMED THE ABSENCE OF ESBL PRODUCING BACTERIA, BUT AN INCREASE OF INHIBITION DIAMETERS BETWEEN BOTH MEDIA CONFIRMED THE PRESENCE OF CEPHALOSPORINASE (AMPC) - KEY HOLE TEST WAS ALSO PERFORMED AND PROVIDED THE SAME NEGATIVE RESULTS (NO SYNERGY, THEN NO ESBL) REFERENCE METHOD: - BROTH MICRODILUTION (BMD) WHICH WAS THE METHOD USED FOR CTX (FORMULATION CTX02N) AND CAZ DEVELOPMENT (FORMULATION CAZ02N) ON AST-N350 CARD: - MIC CTX = 0.5 MG/L (SUSCEPTIBLE) - MIC CAZ = 2 MG/L (INTERMEDIATE) ALTERNATE AND REFERENCE TESTING METHODS INDICATE THE STRAIN IS NOT ESBL-PRODUCING BACTERIA. VITEK 2 AST TESTING INCLUDED: - VITEK 2 AST-N350 CARD [CUSTOMER LOT (7900756403 CALLED CL) ,AND RANDOM LOT (7900841203 CALLED RL)] WERE SUBCULTURED FROM CBA (COS) MEDIUM. - THE AST-N350 CARDS GAVE "ACQUIRED PASE + CASE (AMPC), IRT , ESBL, ACQUIRED PENICILLINASE, CEPHALOSPORINASE (AMPC)" ON THE CL, AND "EXTENDED SPECTRUM BETA LACTAMASE OR SHV1 HYPERPRODUCTION" ON THE RL. THE INVESTIGATION CONCLUDED A SLIGHT MIC OVERESTIMATION OF CEFOTAXIME WAS OBSERVED, WHICH LEADS TO THE FALSE ESBL PHENOTYPE. THE PATIENT ISOLATE IS AN ATYPICAL STRAIN AND WILL BE ADDED TO BIOMÉRIEUX R&D STOCK COLLECTION.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE RESISTANT RESULTS, ASSOCIATED WITH THE INACCURATE DETECTION OF THE ESBL PHENOTYPE, WHEN TESTING WITH THE VITEK® 2 AST-N350 TEST KIT. THE CUSTOMER TESTED AN ESCHERICHIA COLI STRAIN TWICE, AND THE ESBL PHENOTYPE WAS PROPOSED EACH TIME. THE ESBL MAST DISC TEST WAS NEGATIVE. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARMED OR TREATED INCORRECTLY DUE TO THE DISCREPANT RESULT. THE CUSTOMER STATED A DELAY OF 24 HOURS IN REPORTING RESULTS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008126 VITEK® 2 AST-N350 VITEK® 2 AST-N350 LON BIOMERIEUX, INC. 7900756403

    Patients

    Seq Age Sex Outcome Treatment
    1