BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 SYSTEMS SOFTWARE VERSION 8.01

    MDR report key: 8080948 · Received November 16, 2018

    Report

    Report Number
    1950204-2018-00518
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Report Date
    April 1, 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

    AN INTERNAL INVESTIGATION WAS PERFORMED DUE TO A FALSE POSITIVE DETECTION OF ESBL PHENOTYPE (FALSE RESISTANCE) WHEN TESTING TWO ESCHERICHIA COLI STRAINS (S1, S2) IN ASSOCIATION WITH THE VITEK® 2 AST-N351 TEST KIT (REF 421257) AND THE VITEK 2 ADVANCED EXPERT SYSTEM (AES) SOFTWARE. IDENTIFICATION OF THE ORGANISMS WERE CONFIRMED, AND TESTING INCLUDED THE CUSTOMER LOTS (7910757103 & 7910804203 CALLED CL1 AND CL2) AS WELL AS A RANDOM LOT (7910693403 CALLED RL) OF AST-N351 CARDS FROM CBA SUBCULTURE. IN PARALLEL, THE REFERENCE METHOD TO DETERMINE THE MECHANISM OF RESISTANCE WAS PERFORMED FOR BOTH STRAINS : ESBL SCREENING TESTS WITH DISCS COMBINED ON MH +/- CLOXACILLIN, AND KEY HOLE TEST CONFIRMED THE ABSENCE OF ESBL PRODUCING BACTERIA. TESTING WITH VITEK 2 V8.01 (AES PARAMETERS : GLOBAL EUROPEAN BASED + PHENOTYPIC) : FOR S1 : AST-N351 CARDS GAVE "INHIBITOR RESISTANT PASE (IRT OR OXA) OR ACQUIRED PENICILLINASE" FOR CL1, AND "ESBL" PHENOTYPE ON CL2 AND RL ESBL CUSTOMER RESULT IS PARTIALLY REPRODUCED IN-HOUSE (ON CL2 AND RL). FOR S2 : AST-N351 CARDS GAVE "INHIBITOR RESISTANT PASE (IRT OR OXA) OR ACQUIRED PENICILLINASE" , AND "ESBL, SHV1 HYPERPRODUCTION" PHENOTYPE ON CL1 AND RL. ESBL CUSTOMER RESULT IS PARTIALLY REPRODUCED IN-HOUSE (ON CL1 AND RL). THE ONLY DIFFERENCE OBSERVED BETWEEN ESBL PHENOTYPE AND INHIBITOR RESISTANT PASE (IRT OR OXA) OR ACQUIRED PENICILLINASE IS THE VALUE OF TZP. THE REFERENCE METHOD (BROTH MICRODILUTION) WAS PERFORMED TO CHECK THE TZP MIC : REF TZP MIC S1 = 2/4 MG/L S REF TZP MIC S2 = 64/4 MG/L R CONCLUSION: THE TZP VALUE >= 128MG/L LEADS TO THE FALSE ESBL PHENOTYPE. USING THE REFERENCE TZP MICS, THE AES PROPOSED BOTH PHENOTYPES "ACQUIRED PENICILLINASE"OR "INHIBITOR RESISTANT PENICILLINASE (IRT OR OXA)". NOTE: IN A FUTURE AES VERSION OF THE VITEK 2 SOFTWARE, THE MIC RANGES FOR ESCHERICHIA COLI AND PIPERACILLIN/ TAZOBACTAM WILL BE CHANGED FOR THE "ACQUIRED PENICLLINASE" AND "INHIBITOR RESISTANT PENICILLINASE (IRT OR OXA)"PHENOTYPES. THIS CHANGE CONSISTS IN ADDING TZP MIC >= 128 MG/L AS POSSIBLE MIC FOR BOTH PHENOTYPES. THEN THE ESBL PHENOTYPE WILL NOT BE PROPOSED BY AES.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED IN RESPONSE TO CUSTOMER COMPLAINTS REPORTING AN INCREASE IN THE FREQUENCY OF ESBL PHENOTYPE DETECTION BY THE ADVANCED EXPERT SYSTEM (AES) FOLLOWING THE UPDATE TO VITEK 2 SYSTEMS (V2S) SOFTWARE VERSION 8.01. TESTING BY ALTERNATE METHODS HAS NOT CONFIRMED THE PRESENCE OF ESBL IN IMPACTED STRAINS. CONCLUSION: IN THE AES VERSION 8.01 OF THE VITEK2 SOFTWARE, THE MIC RANGES FOR E. COLI AND PIPERACILLIN/TAZOBACTAM WERE CHANGED FOR THE 'ACQUIRED PENICILLINASE' AND 'INHIBITOR RESISTANT PENICILLINASE' PHENOTYPES. THESE CHANGES CONSISTED IN REMOVING MICS >=128 MG/L AS POSSIBLE MICS FOR BOTH PHENOTYPES. THE CONSEQUENCE IS THAT THIS CHANGE HAS REVEALED A PREEXISTING ISSUE IN THE AES DEFINITION OF THE CEFUROXIME MIC RANGE FOR E. COLI AND ESBLS (CEFUROXIME MICS <=8 MG/L SHOULD PREVENT THE ESBL PROPOSAL). THIS, IN ADDITION TO THE SPECIFIC ANTIBIOTIC CONFIGURATION OF THE AST-N351 CARD AND ABSENCE OF THE ESBL TEST, IS THE ROOT CAUSE OF THE REPORTED INCREASE IN ESBL PHENOTYPE PROPOSAL FOR THE AST-N351 CARD. THIS ISSUE WILL BE CORRECTED IN VITEK 2 SYSTEMS SOFTWARE VERSION 9.02. IT SHOULD BE NOTED THAT THERE ARE NO PUBLISHED PERFORMANCE CLAIMS FOR PHENOTYPE DETECTION BY AES. A FIELD SAFETY CORRECTIVE ACTION (FSCA 4191-1) WAS ISSUED 13-DEC-2018 TO THE UNITED KINGDOM TO ADDRESSES THIS ISSUE IN THE FIELD. THE ASSOCIATED URGENT PRODUCT CORRECTION NOTICE INFORMS CUSTOMERS OF THE ESBL PHENOTYPE PROPOSAL AND DESCRIBES CRITERIA LIMITATIONS TO BE APPLIED VIA A VITEK® 2 BIOART RULE. PMA/510(K) NUMBER CORRECTED TO N50510: S103.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE DETECTION OF ESBL PHENOTYPE (FALSE RESISTANCE) WHEN TESTING ESCHERICHIA COLI IN ASSOCIATION WITH THE VITEK® 2 AST-N351 TEST KIT (REF 421257) AND THE VITEK 2 ADVANCED EXPERT SYSTEM (AES) SOFTWARE. THE CUSTOMER WAS INITIALLY TESTING WITH CLED MEDIA, WHICH IS NON-VALIDATED MEDIA. THE CUSTOMER WAS ASKED TO PERFORM RETESTING. ON (B)(6) 2018, THE CUSTOMER CONFIRMED THAT RETESTING USING VALIDATED MEDIA OBTAINED FALSE POSITIVE DETECTION OF ESBL PHENOTYPE WITH THE AST-N351 CARD. THE CUSTOMER CLAIMS THAT THE AES SYSTEM IS INCORRECTLY DETECTING THE ESBL PHENOTYPE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920870 VITEK® 2 SYSTEMS SOFTWARE VERSION 8.01 VITEK® 2 SYSTEMS SOFTWARE VERSION 8.01 LON BIOMERIEUX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1