BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-N351

    MDR report key: 8064578 · Received November 13, 2018

    Report

    Report Number
    1950204-2018-00498
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Report Date
    March 22, 2019
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    N50510: S103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER CORRECTED TO N50510: S103.

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR A CUSTOMER IN (B)(6) REPORTING A FALSE POSITIVE DETECTION OF ESBL PHENOTYPE FOR AN ESCHERICHIA COLI STRAIN (S1= 18091679) WHEN TESTING WITH THE VITEK® 2 AST-N351 TEST KIT (REF 421257). THE CUSTOMER SUBMITTED STRAIN WAS SUBCULTURED ON CBA (COS BMX) MEDIUM, AND THE IDENTIFICATION WAS CONFIRMED TO E.COLI WITH VITEK 2 GN ID CARDS (LOT : 2410545203 / 2420617203). TESTING WAS PERFORMED WITH CUSTOMER LOTS (7910757103 & 7910693403 CALLED CL1 AND CL2) AND A RANDOM LOT (7910638103 CALLED RL) OF AST-N351 CARDS. IN PARALLEL, THE REFERENCE METHOD TO DETERMINE THE MECHANISM OF RESISTANCE WAS PERFORMED: ESBL SCREENING TESTS WITH DISCS COMBINED ON MH +/- CLOXACILLIN. IT CONFIRMED THE ABSENCE OF ESBL PRODUCING BACTERIA FOR S1, BUT AN INCREASE OF INHIBITION DIAMETERS BETWEEN BOTH MEDIA WAS DETECTED AND THEN CONFIRMED THE PRESENCE OF HIGH LEVEL CEPHALOSPORINASE (AMPC) FOR S1. RESULTS WITH VITEK 2 V8.01 (AES PARAMETERS : GLOBAL EUROPEAN BASED + PHENOTYPIC) : FOR S1 : THE AST-N351 CARDS GAVE AN "ESBL" PHENOTYPE ON THE THREE LOTS TESTED. SO THE ESBL CUSTOMER RESULT WAS REPRODUCED IN-HOUSE. THE ONLY DIFFERENCE OBSERVED BETWEEN THE ESBL PHENOTYPE AND "HIGH LEVEL CEPHALOSPORINASE (AMPC)" PHENOTYPE (OBSERVED WITH DISC COMBINED), IS THE VALUE OF TZP (TAZOBACTAM/PIPERACILLIN). THE BROTH MICRODILUTION (BMD) REFERENCE METHOD WAS PERFORMED TO CHECK THE TZP MIC WHICH WAS S1 = 0.5/4 MG/L S. THE VITEK 2 TZP VALUE (</= 4 MG/L S) IS IN AGREEMENT COMPARED TO THE REFERENCE MIC WITHOUT ANY CATEGORY ERROR. CONCLUSION: FOR S1, THE PHENOTYPE ERROR (ESBL) IS DUE TO THE TZP MIC (</= 4 MG/L S) WHICH IS TOO LOW (2 DOUBLING DILUTIONS TO MATCH WITH THE DEFINED RANGE FOR THE HIGH LEVEL CEPHALOSPORINASE PHENOTYPE IN AES SYSTEM EXPERT), BUT THIS MIC REMAINS IN AGREEMENT WITH REFERENCE TZP MIC OBTAINED ON BMD WITH AN UNUSUAL PROFILE FOR HL. IN THE AES VERSION 9.02 OF THE VITEK 2 SOFTWARE, THE MIC RANGES FOR ESCHERICHIA COLI AND PIPERACILLIN/ TAZOBACTAM WILL BE CHANGED FOR THE "ACQUIRED PENICILLINASE" AND "INHIBITOR RESISTANT PENICILLINASE (IRT OR OXA)"PHENOTYPES. THIS CHANGE CONSISTS IN ADDING TZP MIC >/= 128 MG/L AS POSSIBLE MIC FOR BOTH PHENOTYPES.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE DETECTION OF ESBL PHENOTYPE WHEN TESTING WITH THE VITEK® 2 AST-N351 TEST KIT (REF 421257). THE CUSTOMER REPORTED THE FOLLOWING RESULTS: STRAIN ID= (B)(6); IDENTIFICATION: ESCHERICHIA COLI; ESBL PHENOTYPE PROPOSED; ESBL CONFIRMATION TESTS (BIOMÉRIEUX ETEST®) = NEGATIVE. THE CUSTOMER REPORTED THAT NO PATIENT RESULTS WERE AFFECTED, NO WRONG RESULT WAS REPORTED TO A PHYSICIAN, AND NO PATIENT WAS HARMED OR TREATED INCORRECTLY. THERE WAS A DELAY OF 24 HOURS PER THE CUSTOMER DUE TO CONFIRMATORY TESTING WITH ETEST. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903148 VITEK® 2 AST-N351 VITEK® 2 AST-N351 LON BIOMERIEUX, INC. 7910757103

    Patients

    Seq Age Sex Outcome Treatment
    1