BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-P648 TEST KIT

    MDR report key: 7337992 · Received March 14, 2018

    Report

    Report Number
    1950204-2018-00101
    Event Type
    Malfunction
    Date Received
    March 14, 2018
    Report Date
    July 10, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    K022045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE INVESTIGATION WAS INITIATED DUE TO FALSE SUSCEPTIBLE LINEZOLID (LNZ) RESULTS ON VITEK 2 AST-P648 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 & 42(13%) R. ONLY 16.6% OF PARTICIPANTS IDENTIFIED LINEZOLID RESISTANCE AS INTENDED BY NEQAS SURVEY. THE ISOLATE WAS SUBCULTURED ON COS MEDIUM, AND THE IDENTIFICATION WAS 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 CARD, 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 AST-P648 CARDS FROM THE CUSTOMER LOT AND A RANDOM LOT (CL2 : 7480236203 / RL2 : 7480410103). THE VITEK 2 GAVE LNZ MIC = 2 MG/L S ON BOTH CARDS. THE VITEK 2 LNZ MIC = 2 MG/L IS WITHIN ESSENTIAL AGREEMENT IN COMPARISON WITH THE REFERENCE MIC (2MG/L) OBTAINED IN AGAR DILUTION. CONCLUSION : THE VITEK 2 RESULTS ARE CORRELATED WITH THE LNZ REFERENCE MIC (2 MG/L S). VITEK 2 AST-P648 CARDS PERFORMED AS INTENDED AND NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) CONTACTED BIOMÉRIEUX TO REPORT THE OCCURRENCE OF FALSE SUSCEPTIBLE LINEZOLID FOR NEQAS (DISTRIBUTION 4261 - SPECIMEN 4318) IN ASSOCIATION WITH THE VITEK® 2 AST-P648 TEST KIT. IT IS UNKNOWN IF REPEAT TESTING WAS PERFORMED, OR IF CONFIRMATORY TESTING VIA ALTERNATE METHOD WAS CONDUCTED. IT IS IMPORTANT TO NOTE THAT THE INSTRUCTIONS FOR USE (PACKAGE INSERT) CONTAINS A PRODUCT LIMITATION FOR LINEZOLID 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 SPECIES. 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 SPECIMEN. CULTURE SUBMITTAL WAS REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION; HOWEVER, THE CUSTOMER STATED THE STRAIN IS NO LONGER AVAILABLE. BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183054 VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-P648 TEST KIT VITEK® 2 AST-P648 CARD LON BIOMERIEUX, INC 7480236203

    Patients

    Seq Age Sex Outcome Treatment
    1