BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-P632 TEST KIT

    MDR report key: 7292189 · Received February 23, 2018

    Report

    Report Number
    1950204-2018-00086
    Event Type
    Malfunction
    Date Received
    February 23, 2018
    Report Date
    March 23, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    K022045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER REPORTED A FALSE SUSCEPTIBLE LINEZOLID (LNZ) RESULT FOR AN EXTERNAL QUALITY CONTROL STAPHYLOCOCCUS AUREUS SAMPLE (NEQAS 4318), IN ASSOCIATION WITH THE VITEK® 2 AST-P632 TEST KIT. AN INVESTIGATION WAS PERFORMED. THE CUSTOMER OBTAINED FALSE SUSCEPTIBLE LINEZOLID (LNZ) RESULTS COMPARED TO THE EXPECTED RESULT BY NEQAS SURVEY (16 MG/L R). THE RESULTS OBTAINED ACCORDING TO THE EEQ REPORT ARE : 708 S (83.5%) / 2 I (0.2%) / 138 R (16.3%). SO, ONLY 16.3% OF PARTICIPANTS IDENTIFIED LINEZOLID RESISTANCE AS INTENDED BY NEQAS SURVEY. VITEK 2 INTERPRETATION ACCORDING TO EUCAST 2017 BREAKPOINTS LNZ : [ S </= 4 - R > 4 ]. THE AGAR DILUTION (AD) IS THE REFERENCE METHOD USED TO THE DEVELOPMENT OF THIS FORMULA (LNZ02N) IN AST-P632 CARD : LNZ MIC = 2 MG/L S. THE REPRODUCIBILITY TESTING ON VITEK 2 AST-P632 CARDS FROM TSAB SUBCULTURE, INCLUDED TWO CUSTOMER LOTS (CUSTOMER LOT N°1, CL1 7320346203, CUSTOMER LOT N°2, CL2 7320354403) AND A RANDOM LOT, (RL 7320312403). ALL LOTS GAVE A RESULT OF LNZ MIC = 2 MG/L (S). THE CUSTOMER'S RESULTS WERE DUPLICATED IN-HOUSE AND ARE IN AGREEMENT WITH THE REFERENCE METHOD (AD). THE VITEK 2 RESULTS ARE WITHIN ESSENTIAL AGREEMENT WITH THE REFERENCE AD MIC (2 MG/L) WITHOUT ANY CATEGORY ERROR. THEY ALSO CORRELATED WITH MOST OF THE EEQ REPORT RESULTS (83.5% OF S RESULTS OBTAINED). THE VITEK 2 AST-P632 CARD PERFORMED AS INTENDED AND NO FURTHER ACTION IS REQUIRED. NOTE: LIMITATION FOR THIS CARD 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: LINEZOLID: ENTEROCOCCUS SPP., STAPHYLOCOCCUS SPP., STREPTOCOCCUS AGALACTIAE.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED A FALSE SUSCEPTIBLE LINEZOLID RESULT FOR AN EXTERNAL QUALITY CONTROL STAPHYLOCOCCUS AUREUS SAMPLE (NEQAS 4318), IN ASSOCIATION WITH THE VITEK® 2 AST-P632 TEST KIT. THE CUSTOMER REPORTED THE RESULT WAS LINEZOLID SUSCEPTIBLE (MIC=2), AND THE EXPECTED RESULT WAS RESISTANT. THE SAMPLE WAS CULTURED FOR 24 HOURS ON (B)(6) AGAR AND INCUBATED AT 37°C WITH AIR. THE CUSTOMER NO LONGER HAS THE STRAIN FOR EVALUATION. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137075 VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-P632 TEST KIT VITEK® 2 AST-P632 CARD LON BIOMERIEUX, INC 7320354403

    Patients

    Seq Age Sex Outcome Treatment
    1