BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-P654 TEST KIT

    MDR report key: 7357322 · Received March 21, 2018

    Report

    Report Number
    1950204-2018-00114
    Event Type
    Malfunction
    Date Received
    March 21, 2018
    Report Date
    July 11, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    K032766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS INITIATED DUE TO FALSE SUSCEPTIBLE LINEZOLID RESULTS ON VITEK®2 AST-P654 (V8.01), VITEK® 2 AST-P648 (V7.01) AND VITEK® 2 AST-P632 CARDS (V7.01) WITH AN EEQ STRAIN S. AUREUS (NEQAS #4261). THE LNZ EXPECTED RESULT WAS 16 MG/L R BY NEQAS SURVEY. ACCORDING TO THE NEQAS REPORT, PARTICIPANTS THAT USED AN AUTOMATED METHOD OBTAINED 282 (87%) S AND 42(13%) R AND ALL METHODS MIXED 605 (83.1%) S / 2 (0.3%) I / 121 (16.6%) R. THEREFORE, ONLY 16.6% OF PARTICIPANTS THAT IDENTIFIED LINEZOLID RESISTANCE AS INTENDED BY NEQAS SURVEY. THE ISOLATE WAS SUBCULTURED ON COS MEDIUM, IDENTIFICATION CONFIRMED TO S. AUREUS ON VITEK® 2 GP CARD (2420571103). THE AGAR DILUTION (AD), WHICH IS THE REFERENCE METHOD USED FOR THE DEVELOPMENT OF THIS FORMULARY (LNZ02N) ON THE THREE (3) INCRIMINATED CARDS, AND DISC DIFFUSION WERE ALSO PERFORMED IN PARALLEL. THEY GAVE SUSCEPTIBLE RESULTS: LNZ REF MIC = 2 MG/L AND INHIBITION ZONE DIAMETER = 24 MM. VITEK® 2 TESTING INCLUDED VITEK® 2 AST-P654 AND VITEK® 2 AST-P648 AND AST-P632 CARDS FROM THE CUSTOMER LOTS (CALLED CL1 / CL2 / CL3) AND RANDOM LOTS (CALLED RL1 / RL2 / RL3): · AST-P654 (CL1: 8040347103 / RL1 : 8040586203). · AST-P648 (CL2 : 7480236203 / RL2 : 7480410103). · AST-P632 (CL3: 7320346203 / RL3 : 7320312403). THE VITEK® 2 GAVE LNZ MIC = 2 MG/L S ON ALL CARDS TESTED EXCEPT THE FIRST TIME, LNZ MIC => 8 MG/L ON AST-P654 CL1. THE VITEK® 2 LNZ MIC = 2 MG/L IS WITHIN ESSENTIAL AGREEMENT IN COMPARISON WITH THE REFERENCE MIC (2MG/L) OBTAINED IN AGAR DILUTION AND NO CATEGORY ERROR. THE VITEK® 2 LNZ MIC => 8 MG/L IS DUE TO ATYPICAL GROWTH IN THIS CARD CL NOT DUPLICATED IN RL. CONCLUSION : -SUSCEPTIBLE VITEK® 2 RESULTS ARE CORRELATED WITH THE LNZ REF MIC (2 MG/L S). -VITEK® 2 AST-P648 / AST-P632 / AST-P654 CARDS PERFORMED AS INTENDED AND NO FURTHER ACTION IS REQUIRED. -NOTES: BIOMÉRIEUX RESULTS ARE CORRELATED WITH MOST OF THE EEQ PARTICIPANTS REPORTING RESULTS (83% OF SUSCEPTIBLE RESULTS). THE RESISTANT RESULT OBTAINED IN DISC DIFFUSION METHOD BY THE CUSTOMER WAS NOT REPRODUCED IN-HOUSE.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A (B)(6) LINEZOLID RESULT FOR A NEQAS STAPHYLOCOCCUS AUREUS STRAIN, IN ASSOCIATION WITH THE VITEK® 2 AST-P654 TEST KIT. THE CUSTOMER PERFORMED ALTERNATE METHOD TESTING - LINEZOLID ETEST® OBTAINED A RESULT OF MIC=8, AND DISC DIFFUSION RESULT WAS RESISTANT AT 18MM. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT DIRECTLY ASSOCIATED WITH THE NEQAS STRAIN. IT IS IMPORTANT TO NOTE THAT THE AST-P654 INSTRUCTIONS FOR USE CONTAIN A LIMITATION REGARDING THE CORRESPONDING LINEZOLID FORMULATION THAT STATES: "THE ABILITY OF THE AST CARD TO DETECT RESISTANCE WITH THE FOLLOWING COMBINATION(S) IS UNKNOWN BECAUSE RESISTANT STRAINS WERE NOT AVAILABLE AT THE TIME OF COMPARATIVE TESTING" AND INCLUDES (STAPHYLOCOCCUS AUREUS SPECIES. CULTURE SUBMITTAL HAS BEEN REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203478 VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-P654 TEST KIT VITEK® 2 AST-P654 CARD LON BIOMERIEUX, INC 8040347103

    Patients

    Seq Age Sex Outcome Treatment
    1