BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-GN80 TEST KIT

    MDR report key: 6960117 · Received October 18, 2017

    Report

    Report Number
    1950204-2017-00344
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Report Date
    January 19, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    K161227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM THE UNITED STATES REPORTED TO BIOMÉRIEUX DISCREPANT CEFEPIME RESULTS IN ASSOCIATION WITH THE VITEK® 2 AST-GN80 TEST KIT. THE CUSTOMER SUBMITTED THE ISOLATES FOR EVALUATION. AN INVESTIGATION WAS PERFORMED. THE STRAIN IDENTIFICATION WAS CONFIRMED. TESTING INCLUDED BOTH THE CUSTOMER LOT AND A RANDOM LOT OF AST-GN80 CARDS. AGAR DILUTION (AD), WHICH IS THE REFERENCE METHOD FOR CEFEPIME (FEP), WAS ALSO PERFORMED. ISOLATE 911459 (E. COLI): BOTH CARDS TESTED GAVE MICS=8, WHICH WERE CORRECTED TO RESISTANT BY AES. AD GAVE AN INTERMEDIATE MIC=16. THOUGH THIS IS A MINOR CATEGORY ERROR, CARD AND REFERENCE MICS ARE ONLY 1 DOUBLING DILUTION APART, WHICH IS ACCEPTABLE FOR VITEK 2. ISOLATE 911460(K. PNEUMONIAE): BOTH CARDS TESTED GAVE MICS=4, WHICH WERE CORRECTED TO RESISTANT BY AES. AD GAVE A SUSCEPTIBLE MIC=8. CARD AND REFERENCE METHOD MICS ARE ONLY 1 DOUBLING DILUTION APART, WHICH IS ACCEPTABLE FOR VITEK 2. ISOLATE 911461 (K. PNEUMONIAE): BOTH CARDS TESTED GAVE RESISTANT MICS=32, AND AD GAVE AN INTERMEDIATE MIC=16. THOUGH THIS IS A MINOR CATEGORY ERROR, CARD AND REFERENCE MICS ARE ONLY 1 DOUBLING DILUTION APART, WHICH IS ACCEPTABLE FOR VITEK 2. 911462 (K. PNEUMONIAE): BOTH CARDS TESTED GAVE MICS=4, WHICH WERE CORRECTED TO RESISTANT BY AES. AD GAVE AN INTERMEDIATE MIC=16. THIS IS A MINOR CATEGORY ERROR, AND ESSENTIAL AGREEMENT ERROR SINCE CARD AND REFERENCE MICS ARE 2 DOUBLING DILUTIONS APART. THIS ISOLATE IS AN ATYPICAL STRAIN. THE VITEK 2 AST-GN80 CARDS PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE UNITED STATES REPORTED TO BIOMÉRIEUX DISCREPANT CEFEPIME RESULTS IN ASSOCIATION WITH THE VITEK® 2 AST-GN80 TEST KIT. THE CUSTOMER WAS PERFORMING A VALIDATION STUDY TO LOWER CARBAPENEM AND CEPHALOSPORIN BREAKPOINTS USING A CDC BREAKPOINT VALIDATION KIT. VALIDATION WAS SUCCESSFUL EXCEPT FOR CEFEPIME ON SIX (6) OF THIRTEEN (13) CDC ISOLATES WHERE THE MIC WAS > 2 DOUBLING DILUTIONS FROM THE EXPECTED VALUE. THE CUSTOMER REPORTED THAT CEFEPIME VALUES DO NOT MATCH THE CDC VALUES. THE CUSTOMER SENT THE SAMPLES TO A REFERENCE LAB (VITEK® USER) WHICH PRODUCED THE SAME RESULTS AS THE CUSTOMER. THE CDC STATED THEIR RESULTS WERE GENERATED USING IN HOUSE BROTH MICRODILUTION (BMD) PANELS AND NOT VITEK® AND THAT MIC RESULTS FOR EACH ANTIMICROBIAL AGENT FOR AN ISOLATE MAY COMMONLY BE +/- 1 LOG2 (DOUBLING DILUTION) DIFFERENT THAN WHAT IS POSTED ON THE FDA-CDC AR BANK WEBSITE. THE CDC SUGGESTED TO CONSIDER TESTING AN ADDITIONAL SET OF ISOLATES WHOSE MIC VALUES SPAN THE SDD (SUSCEPTIBLE-DOSE DEPENDENT) RANGE. THE CUSTOMER STATED THEY ARE CURRENTLY USING THE VITEK® 2 AST-GN80 CARDS FOR PATIENT TESTING. THE LAB REPORTS AND STRAINS WERE REQUESTED FROM THE CUSTOMER. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737876 VITEK® 2 AST-GN80 TEST KIT VITEK® 2 AST-GN80 TEST CARD LON BIOMERIEUX, INC 6700399403

    Patients

    Seq Age Sex Outcome Treatment
    1